Nano/Microhybrid Diamond Polisher Superfine Point

GUDID D7794121SP1

COSMEDENT, INC.

Dental abrasive disk, reusable Dental abrasive disk, reusable
Primary Device IDD7794121SP1
NIH Device Record Keyc45aef01-c725-41d4-91f2-e0a0f19e3f2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNano/Microhybrid Diamond Polisher Superfine Point
Version Model Number4121SP
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
HIBCCD7794121SP1 [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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.