DENTCA Try-in

GUDID 00856551007001

DENTCA Try-in - 1 kg - White

DENTCA, INC.

Dental appliance fabrication material, cured
Primary Device ID00856551007001
NIH Device Record Key7a2a23b5-e677-41ba-8284-d0e4238f5d85
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENTCA Try-in
Version Model NumberDENTCA Denture Base II
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 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

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
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

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place. Do not expose to direct sunlight.
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.

Device Identifiers

Device Issuing AgencyDevice ID
GS100856551007001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-04
Device Publish Date2019-03-20

Devices Manufactured by DENTCA, INC.

00856551007520 - DENTCA Base Premium2023-04-11 DENTCA Base Premium - Original Pink - 1kg
00856551007537 - DENTCA Base Premium2023-04-11 DENTCA Base Premium - Light Pink - 1kg
00856551007544 - DENTCA Base Premium2023-04-11 DENTCA Base Premium - Reddish Pink - 1kg
00856551007551 - DENTCA Base Premium2023-04-11 DENTCA Base Premium - Dark Pink - 1kg
00856551007568 - DENTCA Base Hi-Impact2023-04-11 DENTCA Base Hi-Impact - Original Pink - 1kg
00856551007575 - DENTCA Base Hi-Impact2023-04-11 DENTCA Base Hi-Impact - Light Pink - 1kg
00856551007582 - DENTCA Base Hi-Impact2023-04-11 DENTCA Base Hi-Impact - Reddish Pink - 1kg
00856551007599 - DENTCA Base Hi-Impact2023-04-11 DENTCA Base Hi-Impact - Dark Pink - 1kg
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.