FDA.report

Miniscope Telescoping Herbst

Primary DI
00190746141010
Brand
Miniscope Telescoping Herbst
Company
AMERICAN ORTHODONTICS CORPORATION
Model
855-918RPK
Catalog number
855-918RPK
Device description
MINISCOPE TELESCOPING MECHANISM 18MM RIGHT 10/PK
Published
2021-11-02
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
00190746141010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746141010001907461410101907461410100190746141010

GMDN Terms

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

Contacts

PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags

DUNS number
044668515
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
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

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00190746153273PowerScope852-016541852-0165412026-03-24
00190746202742PowerScope852-016538852-0165382026-03-24
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00190746191602Empower Bracket475-1112VSCC475-1112VSCC2026-03-23
00190746191619Empower Bracket475-128VSCC475-128VSCC2026-03-23
00190746191626Empower Bracket475-2112VSCC475-2112VSCC2026-03-23
00190746191633Empower Bracket475-228VSCC475-228VSCC2026-03-23
00190746191640Empower Bracket475-310VSCC475-310VSCC2026-03-23
00190746191657Empower Bracket475-410VSCC475-410VSCC2026-03-23
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00190746191671Empower Bracket585-140BVSCC585-140BVSCC2026-03-23
00190746191688Empower Bracket585-140VSCC585-140VSCC2026-03-23
00190746191695Empower Bracket585-230BVSCC585-230BVSCC2026-03-23
00190746191701Empower Bracket585-240BVSCC585-240BVSCC2026-03-23
00190746191718Empower Bracket585-240VSCC585-240VSCC2026-03-23
00190746191725Empower Bracket585-330BVSCC585-330BVSCC2026-03-23
00190746191732Empower Bracket585-340BVSCC585-340BVSCC2026-03-23

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Primary DIBrandCompanyProduct codePublished
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00190746153273PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746202742PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746202759PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
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EDET047551dx retainer 1000gDETAX GmbHDYJ2026-03-06
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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
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00810126381552Upper saggitalDigital Dental Laboratories, IncDYJ2026-02-25
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