Pedo OnBrace Crown UR2 (5/pk)

GUDID D8199013952

SPECIALTY APPLIANCES, LLC

Preformed dental crown, temporary
Primary Device IDD8199013952
NIH Device Record Key365bee4c-dee3-4ea3-8698-ea0e199bc1dc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePedo OnBrace Crown UR2 (5/pk)
Version Model Number901395
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
HIBCCD8199013950 [Primary]
HIBCCD8199013952 [Package]
Contains: D8199013950
Package: [5 Units]
In Commercial Distribution

FDA Product Code

ECMBand, Preformed, Orthodontic
ELZCrown, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-02
Device Publish Date2024-09-24

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D8199007380 - Printed Pre-Formed Left Cantilever 12mm (Single)2025-02-17
D8199007390 - Printed Pre-Formed Left Cantilever 14mm (Single)2025-02-17
D8199007400 - Printed Pre-Formed Right Cantilever 8mm (Single)2025-02-17
D8199007410 - Printed Pre-Formed Right Cantilever 10mm (Single)2025-02-17
D8199007420 - Printed Pre-Formed Right Cantilever 12mm (Single)2025-02-17
D8199007430 - Printed Pre-Formed Right Cantilever 14mm (Single)2025-02-17

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