All Ceramic Extra Oral Zirconia Cones

GUDID D77941405218

COSMEDENT, INC.

Dental abrasive disk, reusable Dental abrasive disk, reusable
Primary Device IDD77941405218
NIH Device Record Key44f7787a-655d-44d1-bab4-af7496a9fe80
Commercial Distribution StatusIn Commercial Distribution
Brand NameAll Ceramic Extra Oral Zirconia Cones
Version Model Number414052
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
HIBCCD77941405218 [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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