FDA.reportPublic FDA data

Masel

Primary DI
00190707000554
Brand
Masel
Company
Ortho Organizers, Inc.
Model
3904-200
Device description
FACEBOW 045 ONE FOR ALL
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K980195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980195000FACEBOWOrtho Kinetics Corp.1998-03-11DZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707000554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707000554001907070005541907070005540190707000554

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic face bowA dental device used in conjunction with extraoral traction anchored on the back of the head or neck, as a long metal bow that inserts intraorally into an orthodontic appliance. Generally used to move teeth or bones posteriorly or prevent their forward movement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062165188
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190707133207Band Assemblies900-123061E-0202025-07-07
00190707134341Band Assemblies900-124061E-0202025-07-07
00190707140021Band Assemblies900-103061E-032025-07-07
00190707140366Band Assemblies900-104061E-032025-07-07
00190707141387Band Assemblies900-123061E-032025-07-07
00190707141516Band Assemblies900-124061E-032025-07-07
00190707192976Aria® Expressions®716-303CH-102026-08-27
00190707192983Aria® Expressions®716-304CH-102026-08-27
00190707192990Aria® Expressions®716-321CH-102026-08-27
00190707193003Aria® Expressions®716-322CH-102026-08-27
00190707193010Aria® Expressions®716-333CH-102026-08-27
00190707193027Aria® Expressions®716-351CH-HK-102026-08-27
00190707193034Aria® Expressions®716-352CH-HK-102026-08-27
00190707193041Aria® Expressions®716-359CH-HK-102026-08-27
00190707193058Aria® Expressions®716-360CH-HK-102026-08-27
00190707193065Aria® Expressions®716-369CH-HK-102026-08-27
00190707193072Aria® Expressions®716-370CH-HK-102026-08-27
00190707193089Aria® Expressions®716-389CH-HK-102026-08-27
00190707193096Aria® Expressions®716-390CH-HK-102026-08-27
00190707193102Aria® Expressions®716-393CH-HK-102026-08-27

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