FDA.report

ORTHOSOURCE

Primary DI
D91120090
Brand
ORTHOSOURCE
Company
ORTHOSOURCE
Model
2009
Device description
Single Tooth Movement Screw 2009
Published
2022-10-26
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DYJRetainer, Screw Expansion, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D91120090PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic palate expander/teeth aligner, self-removableAn orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism with clasps and/or wires. It is not fixed to the oral cavity so that it can be temporarily removed and reapplied by the patient during the treatment period (e.g., for eating). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
151289394
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 DIBrandModelCatalogPublished
D911618002W1000ORTHOSOURCE618-002W2022-11-11
D9116180040ORTHOSOURCE618-0042022-11-11
D911618004W1000ORTHOSOURCE618-004W2022-11-11
D9116180060ORTHOSOURCE618-0062022-11-11
D911618006W1000ORTHOSOURCE618-006W2022-11-11
D9116180080ORTHOSOURCE618-0082022-11-11
D911618008W1000ORTHOSOURCE618-008W2022-11-11
D9116180140ORTHOSOURCE618-0142022-11-11
D911618014W1000ORTHOSOURCE618-014W2022-11-11
D9116180161000ORTHOSOURCE618-0162022-11-11
D911618016W1000ORTHOSOURCE618-016W2022-11-11
D9116180171000ORTHOSOURCE618-0172022-11-11
D911618017W1000ORTHOSOURCE618-017W2022-11-11
D9116180181000ORTHOSOURCE618-0182022-11-11
D911618018W1000ORTHOSOURCE618-018W2022-11-11
D9116180191000ORTHOSOURCE618-0192022-11-11
D911618019W1000ORTHOSOURCE618-019W2022-11-11
D9116180201000ORTHOSOURCE618-0202022-11-11
D911618020W1000ORTHOSOURCE618-020W2022-11-11
D9116180211000ORTHOSOURCE618-0212022-11-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00190746067501Quick FixAMERICAN ORTHODONTICS CORPORATIONDYJ2026-01-28
00190746067525Quick FixAMERICAN ORTHODONTICS CORPORATIONDYJ2026-01-28
00190746067600Rapid Molar IntruderAMERICAN ORTHODONTICS CORPORATIONDYJ2026-01-28