DENTCA Denture Teeth

GUDID 00856551007315

1kg DENTCA Denture Teeth - A2

DENTCA, INC.

Resin artificial teeth
Primary Device ID00856551007315
NIH Device Record Key463d3e2d-0926-4abc-8af5-a47a270b0010
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENTCA Denture Teeth
Version Model NumberDENTCA Denture Teeth
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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

Device Dimensions

Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram
Weight1 Kilogram

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
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
GS100856551007315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-04
Device Publish Date2017-07-07

On-Brand Devices [DENTCA Denture Teeth]

008565510073531kg DENTCA Denture Teeth - B2
008565510073461 kg DENTCA Denture Teeth - B1
008565510073391kg DENTCA Denture Teeth - A3.5
008565510073221kg DENTCA Denture Teeth - A3
008565510073151kg DENTCA Denture Teeth - A2
008565510073081kg DENTCA Denture Teeth - A1
008565510073601kg DENTCA Denture Teeth - BL1

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