FDA.reportPublic FDA data

Ortho Pro

Primary DI
00810152826331
Brand
Ortho Pro
Company
Ortho Pro Dent LLC
Model
CSS-LR-M42
Device description
Bondable Lingual Retainers Maxillary 42 mm 10 pcs/pk
Published
2024-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZCWire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810152826331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152826331008101528263318101528263310810152826331

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic wireA thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
941-402-6504edward@orthoprodent.com

Regulatory Flags#

DUNS number
085719913
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810152820902MAX-BONDOP96b-042024-11-04
00810152820919MAX-BONDOP96b-152024-11-04
00810152825556Orthodontic PlierOP-1002024-11-06
00810152825563Orthodontic PlierOP-1022024-11-06
00810152825570Orthodontic PlierOP-1032024-11-06
00810152825587Orthodontic PlierOP-1042024-11-06
00810152825594Orthodontic PlierOP-1052024-11-06
00810152825600Orthodontic PlierOP-1062024-11-06
00810152825617Orthodontic PlierOP-1072024-11-06
00810152825624Orthodontic PlierOP-1082024-11-06
00810152825631Orthodontic PlierOP-1092024-11-06
00810152825648Orthodontic PlierOP-1102024-11-06
00810152825655Orthodontic PlierOP-1112024-11-06
00810152825662Orthodontic PlierOP-1122024-11-06
00810152825679Orthodontic PlierOP-1132024-11-06
00810152825686Orthodontic PlierOP-1142024-11-06
00810152825693Orthodontic PlierOP-1152024-11-06
00810152825709Orthodontic PlierOP-1162024-11-06
00810152825716Orthodontic PlierOP-1172024-11-06
00810152825723Orthodontic PlierOP-1182024-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898488900621KIT THERMO 35° WIRES - ROUNDS + RECTANGULARS - 100 TENSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611211231STRAIGHT WIRE SS COLBOLOY 0.016X0.022 - RECTANGULAR - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216366NEW EUROPA I - SS ROUND OVOID WIRE 0.016 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216373NEW EUROPA I - SS ROUND OVOID WIRE 0.018 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216380NEW EUROPA I - SS ROUND OVOID WIRE 0.020 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216397NEW EUROPA I - SS OVOID SQUARE WIRE 0.016X0.016 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216403NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.016X0.022 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216410NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.017X0.025 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216427NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.018X0.025 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216434NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.019X0.025 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611216441NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.021X0.025 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-27
07908611211736LINGUAL RETAINER STRAIGHT WIRES - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-01-12
07908611212641LINGUAL RETAINER CHAIN - SOFT - 1 METERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-01-12
07908611213853LINGUAL RETAINER CHAIN - HARD - 1 METERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-01-12
07908611210333ICERAM-P MBT 0.022 KIT + 1 PAIR OF ESTHETIC ARCHWIRES + 1 PEARL BLUE MODULARORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-07
07908611211163PREMIUM ELITE KIT ROTH 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-07
07908611211170PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULARORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-07
07908611210319KIT ICERAM-P ROTH 0.022 + 1 PAIR OF ESTHETIC ARCHWIRE + 1 MODULAR PEARL BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-03
07908470704738KIT ADVANCED METAL BRACKETS ROTH 0.022 10 SETS + ARCHES + ELASTICORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908470704776KIT ADVANCED METAL BRACKETS MBT 0.022 10 SETS + ARCHES + ELASTICSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908470704912KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + ELASTICSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908611204264KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908611204271KIT ADVANCED METAL BRACKETS MBT 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07899439270497ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439270503ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439270510ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439272583ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439292949ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07908611210029"PROMO KIT ADVANCED ROTH 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2024-04-16
07908611210036"PROMO KIT ADVANCED ROTH 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2024-04-16