FDA.report

Sierra Cosmetic Brackets

Primary DI
00190746004841
Brand
Sierra Cosmetic Brackets
Company
AMERICAN ORTHODONTICS CORPORATION
Model
002-9811HV
Catalog number
002-9811HV
Device description
COSMETIC SIERRA UL BICUSPID 022 T-7 A=0 R=0 W/HK DIST
Published
2016-11-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DYWBRACKET, PLASTIC, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190746004841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746004841001907460048411907460048410190746004841

GMDN Terms

TermDefinition
Orthodontic bracket, plastic, single-useA plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags

DUNS number
044668515
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00190746191695Empower Bracket585-230BVSCC585-230BVSCC2026-03-23
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00190746191732Empower Bracket585-340BVSCC585-340BVSCC2026-03-23

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