FDA.reportPublic FDA data

Sierra Classic

Primary DI
00190746004278
Brand
Sierra Classic
Company
AMERICAN ORTHODONTICS CORPORATION
Model
002-9311MH
Catalog number
002-9311MH
Device description
COSMETIC SIERRA CLASSIC UL CUSPID 018 T=0 A+11 R4M 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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYWBRACKET, PLASTIC, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746004278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746004278001907460042781907460042780190746004278

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags#

DUNS number
044668515
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190746150012Superelastic Titanium Memory857-54138TQSPW857-54138TQSPW2019-08-12
00190746150029Superelastic Titanium Memory857-54234TQSPW857-54234TQSPW2019-08-12
00190746150036Superelastic Titanium Memory857-54238TQSPW857-54238TQSPW2019-08-12
00190746150098Superelastic Titanium Memory857-551TQSPW857-551TQSPW2019-08-12
00190746150104Superelastic Titanium Memory857-552TQSPW857-552TQSPW2019-08-12
00190746150128Superelastic Titanium Memory857-554TQSPW857-554TQSPW2019-08-12
00190746148354Superelastic Titanium Memory857-731W857-731W2019-08-09
00190746007835Procelain Conditioner001-966001-9662016-11-09
00190746133282Rapid Molar Intruder852-202852-2022018-07-05
00190746133299Rapid Molar Intruder852-203852-2032018-07-05
00190746096112MasterSeries390-8712B390-8712B2018-08-03
00190746096334MasterSeries390-8713B390-8713B2018-08-03
00190746097904MasterSeries390-8716B390-8716B2018-08-03
00190746098093MasterSeries390-8717B390-8717B2018-08-03
00190746203770Weldable Cleat852-166852-1662026-04-21
00190746203787Weldable Cleat852-166PK852-166PK2026-04-21
00190746203794Weldable Cleat852-168PK852-168PK2026-04-21
00190746203800Weldable Cleat852-168852-1682026-04-21
00190746203817Weldable Cleat852-167PK852-167PK2026-04-21
00190746203824Weldable Cleat852-167852-1672026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82966501520000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501520000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501520000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665015200M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665015200M0101Premium LineEC Certification Service GmbHDYW2026-05-26
D829665015200M0501Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501620000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501620000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501620000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665016200M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503110000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031100M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031100M0101Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031100M0501Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503111000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503111000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503111000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031110M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031110M0101Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031110M0501Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503210000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503210000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503210000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032100M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032100M0101Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032100M0501Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503211000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503211000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503211000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032110M0051Premium LineEC Certification Service GmbHDYW2026-05-26