Unilateral denture

GUDID 00810126380319

Digital Dental Laboratories, Inc

Partial denture
Primary Device ID00810126380319
NIH Device Record Keyc68b8367-9110-479c-b66f-1fe5879acd57
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnilateral denture
Version Model Number0319
Company DUNS251537143
Company NameDigital Dental Laboratories, 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 Usetrue
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
GS100810126380319 [Primary]

FDA Product Code

NSKDentures, Partial

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-05
Device Publish Date2026-02-25

Devices Manufactured by Digital Dental Laboratories, Inc

00810126381118 - Nance - Hor Rem2026-03-06
00810126380159 - Set Full Denture2026-03-05
00810126380166 - Finish Full Denture2026-03-05
00810126380173 - Finish Denture - 1-3 Teeth2026-03-05
00810126380180 - Finish Denture - 4-7 Teeth2026-03-05
00810126380197 - Finish Denture - 8+ teeth2026-03-05
00810126380203 - Flipper - 1 to 2 teeth2026-03-05
00810126380210 - Flipper - 3+ teeth2026-03-05

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