FDA.reportPublic FDA data

PowerScope

Primary DI
00190746202742
Brand
PowerScope
Company
AMERICAN ORTHODONTICS CORPORATION
Model
852-016538
Catalog number
852-016538
Device description
FIXED FUNCT POWERSCOPE 5/KIT
Published
2026-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00190746202742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746202742001907462027421907462027420190746202742

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic rod-based alignerAn orthodontic device which includes a rod(s) intended to be bonded to teeth to correct malocclusions (e.g., overbites); it is commonly known as Herbst appliance. The rod, also referred to as a piston or tube, is typically positioned with a metal band and/or bracket and incorporates a hinge-like mechanism to allow jaw opening/closing. 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(800)558-7687info@americanortho.com

Regulatory Flags#

DUNS number
044668515
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190746062896BracePaste Fluoride Sealant Kit020-039668020-0396682024-10-28
00190746188800BracePaste Fluoride Sealant020-035993020-0359932024-10-10
00190746059193BracePaste020-026877020-0268772022-10-05
00190746059209BracePaste020-026878020-0268782022-10-05
00190746059216BracePaste020-026879020-0268792022-10-05
00190746059223BracePaste020-026880020-0268802022-10-05
00190746059254BracePaste MTP Light Cure Primer020-029614020-0296142022-10-05
00190746059261BracePaste MTP Kit020-030089020-0300892022-10-05
00190746059285BracePaste020-031573020-0315732022-10-05
00190746059292BracePaste020-031574020-0315742022-10-05
00190746059322BracePaste020-031575020-0315752022-10-05
00190746059339Bracepaste Band and Build LC020-032026020-0320262022-10-05
00190746059346Bracepaste Band and Build LC020-032027020-0320272022-10-05
00190746059476Carbide BurFG118LFG118L2022-10-05
00190746059506Carbide BurFG118SFG118S2022-10-05
00190746059513Carbide BurFG218FG2182022-10-05
00190746059520Carbide BurFG283-014FG283-0142022-10-05
00190746059551Diamond BurFG392-016FFG392-016F2022-10-05
00190746059568Carbide BurFG699LFG699L2022-10-05
00190746059575Carbide BurFG7675FG76752022-10-05

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