FDA.reportPublic FDA data

OrthoQuest

Primary DI
00840326406328
Brand
OrthoQuest
Company
Young Innovations, Inc.
Model
L0171
Catalog number
L0171
Device description
PULL HEAD CAP RED LARGE
Published
2022-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZBHeadgear, extraoral, orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZBHeadgear, Extraoral, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961754000SAFETY RELEASE MODULEG & H Wire Co.1996-07-10DZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840326406325PackageGS15In Commercial Distribution
00840326406328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084032640632510840326406325
00840326406328008403264063288403264063280840326406328

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic chin cap/cupA dental device component of an extraoral orthodontic headgear designed to help reduce/correct mandibular prognathism by applying reverse pull force to the chin, via tight attachment to the headgear head straps. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 558-6684support@youngspecialties.com

Regulatory Flags#

DUNS number
004193103
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843471120460DefendVP-8104VP-81042022-10-30
00843471120477DefendVP-8104TVP-8104T2022-10-30
00843471120484DefendVP-8105VP-81052022-10-30
00843471120491DefendVP-8105TVP-8105T2022-10-30
00843471120514DefendVP-8106VP-81062022-10-30
00843471120521DefendVP-8106TVP-8106T2022-10-30
00843471120538DefendVP-8107VP-81072022-10-30
00843471120545DefendVP-8108VP-81082022-10-30
00843471120552DefendVP-8108TVP-8108T2022-10-30
00843471120569DefendVP-8111VP-81112022-10-30
00843471120576DefendVP-8111TVP-8111T2022-10-30
00843471120583DefendVP-8140VP-81402022-10-30
00843471120590DefendVP-8140TVP-8140T2022-10-30
00843471120606DefendVP-8150TVP-8150T2022-10-30
00843471120637DefendVP-8165TVP-8165T2022-10-30
00843471143926Defend2926272926272022-10-30
00843471152782DefendCS-0100CS-01002022-10-30
00840326426630Astek1002991002992026-05-11
00840326423851Astek19025190252025-03-17
00840326423868Astek19026190262025-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10190886051818NAG & H Wire Company, Inc.DZB2025-03-31
10190886051825NAG & H Wire Company, Inc.DZB2025-03-31
10190886051832NAG & H Wire Company, Inc.DZB2025-03-31
10190886051849NAG & H Wire Company, Inc.DZB2025-03-31
10190886051856NAG & H Wire Company, Inc.DZB2025-03-31
10190886051863NAG & H Wire Company, Inc.DZB2025-03-31
10190886051870NAG & H Wire Company, Inc.DZB2025-03-31
10190886051887NAG & H Wire Company, Inc.DZB2025-03-31
10190886051894NAG & H Wire Company, Inc.DZB2025-03-31
10190886051900NAG & H Wire Company, Inc.DZB2025-03-31
10190886051917NAG & H Wire Company, Inc.DZB2025-03-31
10190886051924NAG & H Wire Company, Inc.DZB2025-03-31
10190886051931NAG & H Wire Company, Inc.DZB2025-03-31
10190886051948NAG & H Wire Company, Inc.DZB2025-03-31
10190886052020NAG & H Wire Company, Inc.DZB2025-03-31
10190886052037NAG & H Wire Company, Inc.DZB2025-03-31
10190886052044NAG & H Wire Company, Inc.DZB2025-03-31
10190886052051NAG & H Wire Company, Inc.DZB2025-03-31
10190886052068NAG & H Wire Company, Inc.DZB2025-03-31
10190886052075NAG & H Wire Company, Inc.DZB2025-03-31
10190886155226NAG & H Wire Company, Inc.DZB2025-03-31
10190886155233NAG & H Wire Company, Inc.DZB2025-03-31
10190886155240NAG & H Wire Company, Inc.DZB2025-03-31
10190886155257NAG & H Wire Company, Inc.DZB2025-03-31
10190886155264NAG & H Wire Company, Inc.DZB2025-03-31
10195291008266N/AFlexmedicsDZB2020-05-26
10195291009133N/AFlexmedicsDZB2020-05-26
10195291009140N/AFlexmedicsDZB2020-05-26
10195291009157N/AFlexmedicsDZB2020-05-26
10195291009164N/AFlexmedicsDZB2020-05-26