Formlabs Denture Teeth resin

GUDID 00856551007735

1L Formlabs Denture Teeth resin - A3.5

DENTCA, INC.

Resin artificial teeth
Primary Device ID00856551007735
NIH Device Record Key1ec56833-4ce0-4279-85ae-92bf90a0d3ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameFormlabs Denture Teeth resin
Version Model NumberFormlabs Denture Teeth 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

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100856551007735 [Primary]

FDA Product Code

PZYAdditively Manufactured, Preformed, Resin Denture Tooth

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 Teeth resin]

008565510077661L Formlabs Denture Teeth resin - BL1
008565510077591L Formlabs Denture Teeth resin - B2
008565510077421L Formlabs Denture Teeth resin - B1
008565510077351L Formlabs Denture Teeth resin - A3.5
008565510077281L Formlabs Denture Teeth resin - A3
008565510077111L Formlabs Denture Teeth resin - A2
008565510077041L Formlabs Denture Teeth resin - A1
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