FDA.reportPublic FDA data

MR1

Primary DI
00190746182730
Brand
MR1
Company
AMERICAN ORTHODONTICS CORPORATION
Model
940-0R-0900
Catalog number
940-0R-0900
Device description
BAND MR1 MAX RIGHT 2ND MOLAR SZ 9
Published
2022-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECMBAND, PREFORMED, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746182730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746182730001907461827301907461827300190746182730

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
00840018667815Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECM2025-11-06
10190707120051TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120068TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120075TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120082TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120099TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120105TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120112TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120129TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120136TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120143TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120150TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120167TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120174TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120181TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120198TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120204TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120211TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120228TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120235TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120242TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120259TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120266TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120273TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120280TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120297TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120303TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120310TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120327TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120334TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17