Nance - Hor Rem

GUDID 00810126381118

Digital Dental Laboratories, Inc

Orthodontic retainer
Primary Device ID00810126381118
NIH Device Record Key05e7cc53-8c9a-481d-9e67-203463b4d66e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNance - Hor Rem
Version Model Number1118
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
GS100810126381118 [Primary]

FDA Product Code

ECNClamp, Wire, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-06
Device Publish Date2026-02-26

Devices Manufactured by Digital Dental Laboratories, Inc

00810126381118 - Nance - Hor Rem2026-03-06
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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