FDA.reportPublic FDA data

Top Quality Manufacturing

Primary DI
TQ26126033151
Brand
Top Quality Manufacturing
Company
TOP QUALITY MANUFACTURING, INC.
Model
12603315
Device description
TQMPL Single Use Diamond - Round - 801-014C - Coarse
Published
2024-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZPINSTRUMENT, DIAMOND, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
TQ26126033151PrimaryHIBCC0
TQ26126033150Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, single-useA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-8559regulatory@topqualitygloves.com

Regulatory Flags#

DUNS number
113630649
Device count
25
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
TQ26126092411Top Quality Manufacturing126092412024-10-30
TQ26126092431Top Quality Manufacturing126092432024-10-28
TQ26126092441Top Quality Manufacturing126092442024-10-28
TQ26126092501Top Quality Manufacturing126092502024-10-28
TQ26126092521Top Quality Manufacturing126092522024-10-28
TQ26126092531Top Quality Manufacturing126092532024-10-28
TQ26126092551Top Quality Manufacturing126092552024-10-28
TQ26126092561Top Quality Manufacturing126092562024-10-28
TQ26126092571Top Quality Manufacturing126092572024-10-28
TQ26126092581Top Quality Manufacturing126092582024-10-28
TQ26126092621Top Quality Manufacturing126092622024-10-28
TQ26126092641Top Quality Manufacturing126092642024-10-28
TQ26126092661Top Quality Manufacturing126092662024-10-28
TQ26126092681Top Quality Manufacturing126092682024-10-28
TQ26126092691Top Quality Manufacturing126092692024-10-28
TQ26126092701Top Quality Manufacturing126092702024-10-28
TQ26126092721Top Quality Manufacturing126092722024-10-28
TQ26126092731Top Quality Manufacturing126092732024-10-28
TQ26126092791Top Quality Manufacturing126092792024-10-28
TQ26126092831Top Quality Manufacturing126092832024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243660995Alpen DiamondsDent4You AGDZP2026-09-04
07630243661237Alpen DiamondsDent4You AGDZP2026-09-04
07630243662470Alpen DiamondsDent4You AGDZP2026-09-04
07630243662494Alpen DiamondsDent4You AGDZP2026-09-04
07630243662517Alpen DiamondsDent4You AGDZP2026-09-04
07630243662531Alpen DiamondsDent4You AGDZP2026-09-04
07630243662555Alpen DiamondsDent4You AGDZP2026-09-04
07630243662579Alpen DiamondsDent4You AGDZP2026-09-04
07630243662593Alpen DiamondsDent4You AGDZP2026-09-04
07630243662616Alpen DiamondsDent4You AGDZP2026-09-04
07630243662630Alpen DiamondsDent4You AGDZP2026-09-04
07630243662654Alpen DiamondsDent4You AGDZP2026-09-04
07630243662678Alpen DiamondsDent4You AGDZP2026-09-04
07630243662692Alpen DiamondsDent4You AGDZP2026-09-04
07630243662715Alpen DiamondsDent4You AGDZP2026-09-04
07630243662739Alpen DiamondsDent4You AGDZP2026-09-04
07630243662753Alpen DiamondsDent4You AGDZP2026-09-04
07630243662777Alpen DiamondsDent4You AGDZP2026-09-04
07630243662791Alpen DiamondsDent4You AGDZP2026-09-04
07630243662814Alpen DiamondsDent4You AGDZP2026-09-04
07630243662838Alpen DiamondsDent4You AGDZP2026-09-04
07630243662852Alpen DiamondsDent4You AGDZP2026-09-04
07630243662876Alpen DiamondsDent4You AGDZP2026-09-04
07630243662890Alpen DiamondsDent4You AGDZP2026-09-04
07630243662913Alpen DiamondsDent4You AGDZP2026-09-04
07630243662937Alpen DiamondsDent4You AGDZP2026-09-04
07630243662951Alpen DiamondsDent4You AGDZP2026-09-04
07630243662975Alpen DiamondsDent4You AGDZP2026-09-04
07630243662999Alpen DiamondsDent4You AGDZP2026-09-04
07630243663019Alpen DiamondsDent4You AGDZP2026-09-04