FDA.reportPublic FDA data

Top Quality Manufacturing

Primary DI
TQ26BC2263710
Brand
Top Quality Manufacturing
Company
TOP QUALITY MANUFACTURING, INC.
Model
BC2-2637
Device description
TQMPL Curing Light Handle Sleeve - Pen Type - Large - 3 1/8in x 12 1/2in
Published
2024-12-09
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
NRDUnit, operative dental, accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
TQ26BC2263711PrimaryHIBCC0
TQ26BC2263710Unit of UseHIBCC0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
113630649
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
06954454013526COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-31
06954454015056COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-31
06954454015063COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-31
06954454015070COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-31
06954454015087COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-31
06954454015094COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-31
06954454006672COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-30
06954454006689COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-30
06954454006696COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-30
06954454006702COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-30
06954454006719COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-30
06954454006726COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-30
06954454006733COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-30
06954454006740COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-30
06954454013984COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-30
06954454006849COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006856COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006863COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006870COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006887COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006894COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006900COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006917COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006924COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454016244COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
04719965090013INTRAORAL CAMERACHUAN FU MEDICAL INSTRUMENT CO., LTD.NRD2026-10-22
06954454006757COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006764COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006771COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006788COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22