Printed Lower ROC Pack for Herbst LL5 12mm

GUDID D8199015812

SPECIALTY APPLIANCES, LLC

Orthodontic metal band
Primary Device IDD8199015812
NIH Device Record Key1a706438-5bfc-483e-8c2d-6c1a95fe79a6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrinted Lower ROC Pack for Herbst LL5 12mm
Version Model Number901581
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
HIBCCD8199015810 [Primary]
HIBCCD8199015812 [Package]
Contains: D8199015810
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

D8199015462 - Printed Upper Crown Pack for Herbst UL52025-04-11
D8199015472 - Printed Upper Crown Pack for Herbst UL62025-04-11
D8199015482 - Printed Upper Crown Pack for Herbst UL72025-04-11
D8199015492 - Printed Upper Crown Pack for Herbst UL82025-04-11
D8199015502 - Printed Lower ROC Pack for Herbst LR4 8mm2025-04-11
D8199015512 - Printed Lower ROC Pack for Herbst LR5 8mm2025-04-11
D8199015522 - Printed Lower ROC Pack for Herbst LR6 8mm2025-04-11
D8199015532 - Printed Lower ROC Pack for Herbst LR7 8mm2025-04-11

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