Printed Lower ROC Pack for Herbst LL6 14mm

GUDID D8199015872

SPECIALTY APPLIANCES, LLC

Orthodontic metal band
Primary Device IDD8199015872
NIH Device Record Keya700a169-35fa-4d74-9e4a-25f555942a9f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrinted Lower ROC Pack for Herbst LL6 14mm
Version Model Number901587
Company DUNS106645484
Company NameSPECIALTY APPLIANCES, LLC
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 Batchtrue
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
HIBCCD8199015870 [Primary]
HIBCCD8199015872 [Package]
Contains: D8199015870
Package: [5 Units]
In Commercial Distribution

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 Date2025-04-11
Device Publish Date2025-04-03

Devices Manufactured by SPECIALTY APPLIANCES, LLC

D8199512450 - G4 NiTi Lingual Wire .010 Small Upper2025-07-28
D8199512460 - G4 NiTi Lingual Wire .010 Small Lower2025-07-28
D8199512470 - G4 NiTi Lingual Wire .010 Medium Upper2025-07-28
D8199512480 - G4 NiTi Lingual Wire .010 Medium Lower2025-07-28
D8199512490 - G4 NiTi Lingual Wire .010 Large Upper2025-07-28
D8199512500 - G4 NiTi Lingual Wire .010 Large Lower2025-07-28
D8199512510 - G4 NiTi Lingual Wire .013 Small Upper2025-07-28
D8199512520 - G4 NiTi Lingual Wire .013 Small Lower2025-07-28

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