Candid Refinement Impression Kit

GUDID 00850004223987

Refinement Impression Kit (Medium Trays) Kett 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 Silicone dental impression material Silicone dental impression material
Primary Device ID00850004223987
NIH Device Record Key5cb0dcfe-5ac3-428c-8728-a98073136078
Commercial Distribution StatusIn Commercial Distribution
Brand NameCandid Refinement Impression Kit
Version Model NumberITISK00001
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
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
GS100850004223987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-04-08
Device Publish Date2021-03-31

Devices Manufactured by CANDID CARE CO.

00850004223987 - Candid Refinement Impression Kit2021-04-08Refinement Impression Kit (Medium Trays) Kett Putty Digital
00850004223987 - Candid Refinement Impression Kit2021-04-08 Refinement Impression Kit (Medium Trays) Kett Putty Digital
08500042230004 - Candid Aligner2020-10-12 Candid Aligner System FA-0001
00850004223222 - Candid Aligner2020-09-07 Candid Aligner System FA-0003
00850004223024 - Candid Impression Kit2020-07-28 August 2020 Promo
00850004223000 - Candid Impression Kit2020-04-13 Candid finished impression kit (Old Tray + Kett Putty + Digital+toothbrush)
00850004223116 - Candid Impression Kit2019-11-06 Candid finished impression kit (Mesh Impression Tray + Kett Putty)
00850004223185 - Candid Impression Kit2019-11-06 Candid finished impression kit (Old Tray + Kett Putty + Digital)
00850004223130 - Candid Redo Impression Kit2019-10-14 Redo Impression Kit (Small Trays) Kett Putty Digital

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