FDA.reportPublic FDA data

Ball Hooks

Primary DI
00190746133770
Brand
Ball Hooks
Company
AMERICAN ORTHODONTICS CORPORATION
Model
852-181
Catalog number
852-181
Device description
WELD LINGUAL BALL HOOK STEP-UP
Published
2018-07-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECNCLAMP, WIRE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECNClamp, Wire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746133770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746133770001907461337701907461337700190746133770

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic lockA dental device intended to be placed on an orthodontic archwire or rod via screwing, crimping, or soldering, for orthodontic spring activation and/or to prevent the archwire from sliding within the brackets. It may be designed in various forms (e.g., Gurin lock, stop). It does not incorporate a pin or hook. This is a single-patient device that is 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

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
00840456204962JMUJMU DENTAL, INCECN2026-06-25
00840456204979JMUJMU DENTAL, INCECN2026-06-25
00840456204986JMUJMU DENTAL, INCECN2026-06-25
00840456204993JMUJMU DENTAL, INCECN2026-06-25
00840456205006JMUJMU DENTAL, INCECN2026-06-25
00840456205013JMUJMU DENTAL, INCECN2026-06-25
00840456205266JMUJMU DENTAL, INCECN2026-06-25
00840456205273JMUJMU DENTAL, INCECN2026-06-25
00840456205280JMUJMU DENTAL, INCECN2026-06-25
00840456205754JMUJMU DENTAL, INCECN2026-06-25
00840456205761JMUJMU DENTAL, INCECN2026-06-25
00840456205778JMUJMU DENTAL, INCECN2026-06-25
00840456205785JMUJMU DENTAL, INCECN2026-06-25
00840456205792JMUJMU DENTAL, INCECN2026-06-25
00840456205808JMUJMU DENTAL, INCECN2026-06-25
00840456205815JMUJMU DENTAL, INCECN2026-06-25
00840456205822JMUJMU DENTAL, INCECN2026-06-25
00840456205839JMUJMU DENTAL, INCECN2026-06-25
00840456205846JMUJMU DENTAL, INCECN2026-06-25
00840456205853JMUJMU DENTAL, INCECN2026-06-25
00840456205860JMUJMU DENTAL, INCECN2026-06-25
00840456206072JMUJMU DENTAL, INCECN2026-06-25
00840456206355JMUJMU DENTAL, INCECN2026-06-25
00840456221730JMUJMU DENTAL, INCECN2026-05-11
00840456221747JMUJMU DENTAL, INCECN2026-05-11
006522210993343M™ Unitek™ Intraoral Attachments3M UNITEK CORPORATIONECN2026-05-07
00190746203770Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203787Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203794Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203800Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21