FDA.reportPublic FDA data

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
Single use
true

Contact Domains#

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
09120074342118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120074342118091200743421189120074342118

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 716-871-1161xxx@xxx.com

Regulatory Flags#

DUNS number
300597738
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120074342125PowerScrew 16109672026-02-06
09120074342323PowerScrew 08110112026-02-06
09120074343443PowerScrew 14182152026-02-06
09120074343467PowerScrew 10182222026-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850070544849Retainer - NaturalSprintray, Inc.DYJ2026-07-29
00850070544856Retainer - BlackSprintray, Inc.DYJ2026-07-29
00850070544863Retainer - PinkSprintray, Inc.DYJ2026-07-29
00850070544870Retainer - Neon GreenSprintray, Inc.DYJ2026-07-29
08033707106616LEONE SPALEONE SPADYJ2026-07-22
08033707106623LEONE SPALEONE SPADYJ2026-07-22
08033707106630LEONE SPALEONE SPADYJ2026-07-22
08033707106647LEONE SPALEONE SPADYJ2026-07-22
08800113200210NT-TAINERSMILECADDYJ2026-07-22
06975527188057MOLEKURShanghai Coherz Technology Co., Ltd.DYJ2026-06-04
06975527188408MOLEKURShanghai Coherz Technology Co., Ltd.DYJ2026-06-04
08033707104513LEONE SPALEONE SPADYJ2026-05-28
00840456221761JMUJMU DENTAL, INCDYJ2026-05-11
00840456221778JMUJMU DENTAL, INCDYJ2026-05-11
D775AHAD0Hawley Retainer with Adams ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHAR0Hawley Retainer with Arrow ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHBC0Hawley Retainer with Ball ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHCC0Hawley Retainer with Circumferential ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEL0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEP0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMMT0MemotainGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
00197998216633Clarity™Solventum Orthodontics CorporationDYJ2026-04-25
10371347023326Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023333Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023340Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023357Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
D775AEA0Expansion ApplianceGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775AH0Hawley RetainerGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775BKS0Keles SliderGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
00190746202766PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-04-08