FDA.reportPublic FDA data

OrthoQuest

Primary DI
10840326406325
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
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
004193103
Device count
1
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840326426630Astek1002991002992026-05-11
00840326423851Astek19025190252025-03-17
00840326423868Astek19026190262025-03-17
00840326423875Astek19027190272025-03-17
00840326423882Astek19028190282025-03-17
00843471150061Astek19000190002022-10-18
00843471150078Astek19005190052022-10-18
00843471150085Astek19001190012022-10-18
00843471150092Astek19006190062022-10-18
00840326426586Plak Smacker2000622026-04-20
00840326426593Plak Smacker2000632026-04-20
00840326426609Plak Smacker2000642026-04-20
00840326426616Plak Smacker2000652026-04-20
00840326426623Plak Smacker2000662026-04-20
00840326426203Young Specialties2000-02-102000-02-102026-01-26
00840326426210Young Specialties2000-03-102000-03-102026-01-26
00840326426227Young Specialties2000-04-102000-04-102026-01-26
00840326426234Young Specialties2000-05-102000-05-102026-01-26
00840326426241Young Specialties2000-06-102000-06-102026-01-26
00840326426258Young Specialties2000-07-102000-07-102026-01-26

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