FDA.reportPublic FDA data

The Orthodontic Store

Primary DI
10840326406349
Brand
The Orthodontic Store
Company
Young Innovations, Inc.
Model
650-500-BL
Catalog number
650-500-BL
Device description
Nylon Headgear Case, Black
Published
2022-11-02
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
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
10840326406349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084032640634910840326406349

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic extraoral headgearA dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).

Sterilization Methods#

Method table
Method

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