Band loop space regainer

GUDID 00810126381576

Digital Dental Laboratories, Inc

Orthodontic space maintainer
Primary Device ID00810126381576
NIH Device Record Key1e55b85c-e2d1-4d38-9a22-1af3acfff3b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBand loop space regainer
Version Model Number1576
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
GS100810126381576 [Primary]

FDA Product Code

DYTMaintainer, Space Preformed, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-05
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

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.