pinky wood wedges 5011PLUS

GUDID E2995011PLUS9

11mm (XS) 1000 pcs.

Polydentia SA

Dental wedge, single-use
Primary Device IDE2995011PLUS9
NIH Device Record Keyebc1c56f-e752-4e5e-97e9-6d6ddfedef57
Commercial Distribution StatusIn Commercial Distribution
Brand Namepinky wood wedges
Version Model Number5011PLUS
Catalog Number5011PLUS
Company DUNS481461598
Company NamePolydentia SA
Device Count1000
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE2995011PLUS0 [Primary]
HIBCCE2995011PLUS9 [Unit of Use]

FDA Product Code

DZNInstruments, Dental Hand

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-31
Device Publish Date2023-08-23

On-Brand Devices [pinky wood wedges]

E2995011911 mm (XS), 200 pcs.
E2995011PLUS911mm (XS) 1000 pcs.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.