FDA.report

PowerScrew 12

Primary DI
09120074342118
Brand
PowerScrew 12
Company
Tiger Dental GmbH
Model
10965
Device description
Bone Anchorage-Growth Appliances are orthodontic treatment devices intended for correction of malocclusion and promoting bone growth.
Published
2026-02-06
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

Related Records

Contact Domains

Product Codes

CodeName
DYJRetainer, Screw Expansion, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09120074342118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09120074342118091200743421189120074342118

GMDN Terms

TermDefinition
Orthodontic palate expander screw, bondedAn orthodontic device intended to be used as part of a bonded palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to affect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
+1 716-871-1161xxx@xxx.com

Regulatory Flags

DUNS number
300597738
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
09120074342125PowerScrew 16109672026-02-06
09120074342323PowerScrew 08110112026-02-06
09120074343443PowerScrew 14182152026-02-06
09120074343467PowerScrew 10182222026-02-06

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
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
00190746067624Rapid Molar IntruderAMERICAN ORTHODONTICS CORPORATIONDYJ2026-01-28