FDA.reportPublic FDA data

Weldable Cleat

Primary DI
00190746203787
Brand
Weldable Cleat
Company
AMERICAN ORTHODONTICS CORPORATION
Model
852-166PK
Catalog number
852-166PK
Device description
WELD LINGUAL LOW PROFILE CLEAT CUSPID/BICUSPID 100/PK
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
00190746203787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746203787001907462037871907462037870190746203787

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic power armA dental device in the shape of a straight pin or hook designed to accept an elastic band, power chain, spring, or archwire (not included), which apply a force in addition to the main orthodontic archwire, for vertical alignment and/or horizontal positioning of the teeth; it may include a base that functions as an orthodontic lock/stop. The device is typically crimped, soldered, screwed on, or inserted in the slot of an orthodontic attachment (e.g., bracket, band), or on the surface of a tooth for orthodontic traction. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.

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
00190746189258Buccal Tubes851-110851-1102022-03-24
00190746189272Buccal Tubes851-121851-1212022-03-24
00190746189432Buccal Tubes851-182851-1822022-03-24
00190746141249Stainless Steel Brackets002-0070HMURWF002-0070HMURWF2021-09-03
00190746141263Stainless Steel Brackets002-0071HMULWF002-0071HMULWF2021-09-03
00190746141454Stainless Steel Brackets002-477HDLLWF002-477HDLLWF2021-09-03
00190746141461Stainless Steel Brackets002-477HDLRWF002-477HDLRWF2021-09-03
00190746141515Stainless Steel Brackets002-494HDLLWF002-494HDLLWF2021-09-03
00190746141522Stainless Steel Brackets002-494HDLRWF002-494HDLRWF2021-09-03
00190746175442Stainless Steel Brackets092-208BUL092-208BUL2021-09-03
00190746175459Stainless Steel Brackets092-208BUR092-208BUR2021-09-03
00190746176296Stainless Steel Brackets097-211UL097-211UL2021-09-03
00190746176302Stainless Steel Brackets097-211UR097-211UR2021-09-03
00190746177996Stainless Steel Brackets593-004593-0042021-09-03
00190746161575Stainless Steel Brackets091-142BUL091-142BUL2021-08-26
00190746174957Stainless Steel Brackets091-142BUR091-142BUR2021-08-26
00190746175268Stainless Steel Brackets092-006BUL092-006BUL2021-08-26
00190746175275Stainless Steel Brackets092-006BUR092-006BUR2021-08-26
00190746175503Stainless Steel Brackets092-444HDLR092-444HDLR2021-08-26
00190746175510Stainless Steel Brackets092-445HDLL092-445HDLL2021-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07895742245788MorelliDental Morelli LtdaECN2026-07-28
07895742245726MorelliDental Morelli LtdaECN2026-07-27
07895742245771MorelliDental Morelli LtdaECN2026-07-27
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