FDA.reportPublic FDA data

Printed Upper ROC Pack for Herbst UL7

Primary DI
D8199015382
Brand
Printed Upper ROC Pack for Herbst UL7
Company
SPECIALTY APPLIANCES, LLC
Model
901538
Published
2025-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
D8199015382PackageHIBCC5In Commercial Distribution
D8199015380PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
106645484
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D81990023903-Part TS Herbst Kit9002392022-11-21
D81990024004-Part Telescoping Herbst Replacement Parts9002402022-11-21
D8199002410Traditional Herbst Replacement Parts9002412022-11-21
D8199512450G4 NiTi Lingual Wire .010 Small Upper9512452025-07-18
D8199512460G4 NiTi Lingual Wire .010 Small Lower9512462025-07-18
D8199512470G4 NiTi Lingual Wire .010 Medium Upper9512472025-07-18
D8199512480G4 NiTi Lingual Wire .010 Medium Lower9512482025-07-18
D8199512490G4 NiTi Lingual Wire .010 Large Upper9512492025-07-18
D8199512500G4 NiTi Lingual Wire .010 Large Lower9512502025-07-18
D8199512510G4 NiTi Lingual Wire .013 Small Upper9512512025-07-18
D8199512520G4 NiTi Lingual Wire .013 Small Lower9512522025-07-18
D8199512530G4 NiTi Lingual Wire .013 Medium Upper9512532025-07-18
D8199512540G4 NiTi Lingual Wire .013 Medium Lower9512542025-07-18
D8199512550G4 NiTi Lingual Wire .013 Large Upper9512552025-07-18
D8199512560G4 NiTi Lingual Wire .013 Large Lower9512562025-07-18
D8199512570G4 NiTi Lingual Wire .016 Small Upper9512572025-07-18
D8199512580G4 NiTi Lingual Wire .016 Small Lower9512582025-07-18
D8199512590G4 NiTi Lingual Wire .016 Medium Upper9512592025-07-18
D8199512600G4 NiTi Lingual Wire .016 Medium Lower9512602025-07-18
D8199512610G4 NiTi Lingual Wire .016 Large Upper9512612025-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00190746203817Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203824Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203831Bondable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
10371347023203Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023210Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023227Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023234Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023241Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023258Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023265Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023272Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023289Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
07908611211644CRIMPABLE BALL HOOK - UNIVERSAL - 2.7MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611211651CRIMPABLE BALL HOOK - UNIVERSAL - 4,0MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611211668BUTTON WITH LONG HOOK FOR BONDING - LEFT - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212603BUTTON WITH LONG HOOK FOR BONDING - RIGHT - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212634ORTHODONTIC SPUR - 50UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212665ORTHODONTIC BITE TURBO - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212672LINGUAL BUTTON PERFORATED BASE FOR BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611213815BUTTON WITH CAPLIN HOOK FOR BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611214928LONG CRIMPABLE HOOK - RECTANGULAR - LEFT - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611214935LONG CRIMPABLE HOOK - RECTANGULAR - RIGHT - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
00190707124267Ortho Technology®Ortho Organizers, Inc.ECN2025-10-17