FDA.reportPublic FDA data

Ball-End Lingual Hook

Primary DI
00192029041000
Brand
Ball-End Lingual Hook
Company
TP ORTHODONTICS INC
Model
226-031
Device description
Short Hook, Long Offset
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
ECNCLAMP, WIRE, ORTHODONTIC

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192029041000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192029041000001920290410001920290410000192029041000

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. The device is intended to be inserted in the slot of an orthodontic attachment (e.g., bracket, band), or on the surface of a tooth for orthodontic traction, and does not have a lock or stop in its base. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.

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
00840479201399EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201405EXTEND MEASURING DEVICERELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201412EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201429EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201436EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201443EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201450EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00810126381118Nance - Hor RemDigital Dental Laboratories, IncECN2026-02-26
00810126381019Adapt ApplianceDigital Dental Laboratories, IncECN2026-02-25
00810126381026Alf applianceDigital Dental Laboratories, IncECN2026-02-25
00810126381033BiofinisherDigital Dental Laboratories, IncECN2026-02-25
00810126381040Bionator/ActivatorDigital Dental Laboratories, IncECN2026-02-25
00810126381057FraenkelDigital Dental Laboratories, IncECN2026-02-25
00810126381064Habit breaker - removableDigital Dental Laboratories, IncECN2026-02-25
00810126381071HomeoblockDigital Dental Laboratories, IncECN2026-02-25
00810126381088Lingual Arch - Hor remDigital Dental Laboratories, IncECN2026-02-25
00810126381095Lingual Arch - SolderedDigital Dental Laboratories, IncECN2026-02-25
00810126381101Linguarl Arch - Vert RemDigital Dental Laboratories, IncECN2026-02-25
00810126381125Nance - solderedDigital Dental Laboratories, IncECN2026-02-25
00810126381132Nance - Vert RemDigital Dental Laboratories, IncECN2026-02-25
00810126381149OD1Digital Dental Laboratories, IncECN2026-02-25
00810126381156OD2Digital Dental Laboratories, IncECN2026-02-25
00810126381163OD3Digital Dental Laboratories, IncECN2026-02-25
00810126381170OD4Digital Dental Laboratories, IncECN2026-02-25
00810126381187ON1Digital Dental Laboratories, IncECN2026-02-25
00810126381194ON2Digital Dental Laboratories, IncECN2026-02-25
00810126381200ON3Digital Dental Laboratories, IncECN2026-02-25
00810126381217ON4Digital Dental Laboratories, IncECN2026-02-25
00810126381224ON5Digital Dental Laboratories, IncECN2026-02-25
00810126381231PerfectorDigital Dental Laboratories, IncECN2026-02-25