Intra Oral Polisher Superfine Cup

GUDID D77941400617

COSMEDENT, INC.

Dental abrasive disk, reusable Dental abrasive disk, reusable
Primary Device IDD77941400617
NIH Device Record Key50e1bd89-e13a-417f-b568-c33a8c6ecbcf
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntra Oral Polisher Superfine Cup
Version Model Number414006
Company DUNS113911689
Company NameCOSMEDENT, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD77941400617 [Primary]

FDA Product Code

EHLPoint, Abrasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-23
Device Publish Date2020-02-11

Devices Manufactured by COSMEDENT, INC.

D7796722B01 - Bulkfill2022-03-16
D7796722C31 - Bulkfill2022-03-16
D7796722D21 - Bulkfill2022-03-16
D7796722351 - Bulkfill2022-03-09
D7796722A11 - Bulkfill2022-03-09
D7796722A21 - Bulkfill2022-03-09
D7796722A31 - Bulkfill2022-03-09
D7796722B11 - Bulkfill2022-03-09

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