FDA.reportPublic FDA data

Bondable Lingual Retainer

Primary DI
00192029045053
Brand
Bondable Lingual Retainer
Company
TP ORTHODONTICS INC
Model
224-200F
Device description
Upper Central to Central Small
Published
2021-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192029045053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192029045053001920290450531920290450530192029045053

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005432299
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
true
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
00192029050538Tip-Edge PLUS Stainless Steel Brackets296-61122025-02-04
00192029050545Tip-Edge PLUS Stainless Steel Brackets296-61222025-02-04
00192029050552Tip-Edge PLUS Stainless Steel Brackets296-61322025-02-04
00192029050569Tip-Edge PLUS Stainless Steel Brackets296-61422025-02-04
00192029050576Tip-Edge PLUS Stainless Steel Brackets296-61522025-02-04
00192029050583Tip-Edge PLUS Stainless Steel Brackets296-61622025-02-04
00192029050590Tip-Edge PLUS Stainless Steel Brackets296-61722025-02-04
00192029050606Tip-Edge PLUS Stainless Steel Brackets296-61822025-02-04
00192029050613Tip-Edge PLUS Stainless Steel Brackets296-61922025-02-04
00192029050620Tip-Edge PLUS Stainless Steel Brackets296-62022025-02-04
00192029050637Tip-Edge PLUS Stainless Steel Brackets296-62322025-02-04
00192029050644Tip-Edge PLUS Stainless Steel Brackets296-62422025-02-04
00192029050651Tip-Edge PLUS Stainless Steel Brackets296-62522025-02-04
00192029050668Tip-Edge PLUS Stainless Steel Brackets296-62622025-02-04
00192029050675Tip-Edge PLUS Stainless Steel Brackets296-62922025-02-04
00192029050682Tip-Edge PLUS Stainless Steel Brackets296-63022025-02-04
00192029050699Tip-Edge PLUS Stainless Steel Brackets296-63122025-02-04
00192029050705Tip-Edge PLUS Stainless Steel Brackets296-63222025-02-04
00192029050712Tip-Edge PLUS Stainless Steel Brackets296-63322025-02-04
00192029050729Tip-Edge PLUS Stainless Steel Brackets296-63422025-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611204349CLASS II CORRECTOR - ICERAM CLEAR DISTALIZER - 23MM - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADYJ2026-05-26
07908611204356CLASS II CORRECTOR - ICERAM CLEAR DISTALIZER - 25MM - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADYJ2026-05-26
07908611204363CLASS II CORRECTOR - ICERAM CLEAR DISTALIZER - 27MM - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADYJ2026-05-26
00190746067549PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746067563PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746067587PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746153273PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746202742PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746202759PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
EDET047541dx retainer 5 kgDETAX GmbHDYJ2026-03-06
EDET047551dx retainer 1000gDETAX GmbHDYJ2026-03-06
00810126381330Bihelix - RemovableDigital Dental Laboratories, IncDYJ2026-02-25
00810126381347Daytime applianceDigital Dental Laboratories, IncDYJ2026-02-25
00810126381354Inman spring alignerDigital Dental Laboratories, IncDYJ2026-02-25
00810126381408Retainer - 3 to 3 with meshDigital Dental Laboratories, IncDYJ2026-02-25
00810126381415Retainer - 6 mesh padsDigital Dental Laboratories, IncDYJ2026-02-25
00810126381446Retainer - lower clipDigital Dental Laboratories, IncDYJ2026-02-25
00810126381460Retainer - unsolderedDigital Dental Laboratories, IncDYJ2026-02-25
00810126381477Retainer - wrapDigital Dental Laboratories, IncDYJ2026-02-25
00810126381484Retainer- Soldered 2 arrow head claspsDigital Dental Laboratories, IncDYJ2026-02-25
00810126381491Retainer with mushroom springDigital Dental Laboratories, IncDYJ2026-02-25
00810126381538Twin block applianceDigital Dental Laboratories, IncDYJ2026-02-25
00810126381545Upper and lower saggitalDigital Dental Laboratories, IncDYJ2026-02-25
00810126381552Upper saggitalDigital Dental Laboratories, IncDYJ2026-02-25
09120074342118PowerScrew 12Tiger Dental GmbHDYJ2026-02-06
09120074342125PowerScrew 16Tiger Dental GmbHDYJ2026-02-06
09120074342323PowerScrew 08Tiger Dental GmbHDYJ2026-02-06
09120074343443PowerScrew 14Tiger Dental GmbHDYJ2026-02-06
09120074343467PowerScrew 10Tiger Dental GmbHDYJ2026-02-06
00190746021411Distal JetAMERICAN ORTHODONTICS CORPORATIONDYJ2026-01-28