Candid Impression Kit

GUDID 00850004223789

Impression Kit (Medium Trays) Zest Putty Digital

CANDID CARE CO.

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material
Primary Device ID00850004223789
NIH Device Record Keya02dae8c-bd8c-4c2b-acbe-61bf022fde56
Commercial Distribution StatusIn Commercial Distribution
Brand NameCandid Impression Kit
Version Model NumberFGS-0009
Company DUNS108729170
Company NameCANDID CARE CO.
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 Usetrue
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004223789 [Primary]

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [Candid Impression Kit]

00850004223017Candid finished impression kit
00850004223109Candid finished impression kit (Mesh Impression Tray)
00850004223123Candid finished impression kit (Old Tray + Kett Putty + Digital)
00850004223185Candid finished impression kit (Old Tray + Kett Putty + Digital)
00850004223116Candid finished impression kit (Mesh Impression Tray + Kett Putty)
00850004223000Candid finished impression kit (Old Tray + Kett Putty + Digital+toothbrush)
00850004223178Candid finished impression kit (Mesh Impression Tray Low + Reg Impression Tray Up)
00850004223161Candid finished impression kit (Old Tray + Kulz Putty + Digital)
00850004223024August 2020 Promo
00850004223789Impression Kit (Medium Trays) Zest Putty Digital

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.