Formlabs Denture Base resin

GUDID 00856551007612

1L Formlabs Denture Base resin - Light Pink

DENTCA, INC.

Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, cured Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin
Primary Device ID00856551007612
NIH Device Record Key429de60c-853f-4879-aaaa-5a0bc601e899
Commercial Distribution StatusIn Commercial Distribution
Brand NameFormlabs Denture Base resin
Version Model NumberFormlabs Denture Base resin
Company DUNS022455143
Company NameDENTCA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com
Phone+1(424)558-8726
Emailinfo@dentca.com

Device Dimensions

Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
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Total Volume1 Liter
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Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100856551007612 [Primary]

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-08
Device Publish Date2021-10-29

On-Brand Devices [Formlabs Denture Base resin]

008565510076361L Formlabs Denture Base resin - Dark Pink
008565510076291L Formlabs Denture Base resin - Reddish Pink
008565510076121L Formlabs Denture Base resin - Light Pink
008565510076051L Formlabs Denture Base resin - Original Pink

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