Printed Upper Crown Pack for Herbst UL5

GUDID D8199015462

SPECIALTY APPLIANCES, LLC

Orthodontic metal band
Primary Device IDD8199015462
NIH Device Record Key1c444ddf-aab4-43d1-8c29-2439d5b7a753
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrinted Upper Crown Pack for Herbst UL5
Version Model Number901546
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
HIBCCD8199015460 [Primary]
HIBCCD8199015462 [Package]
Contains: D8199015460
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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