FDA.reportPublic FDA data

Top Quality Manufacturing

Primary DI
TQ26126092970
Brand
Top Quality Manufacturing
Company
TOP QUALITY MANUFACTURING, INC.
Model
12609297
Device description
TQMPL Smart-Blue Gutta Percha Points - .04 - Assorted
Published
2024-10-28
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
EKMGUTTA-PERCHA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
TQ26126092971PrimaryHIBCC0
TQ26126092970Unit 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
60
DM exempt
true
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
true
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
06970157003916Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003947Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003954Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003961Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003978Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003985Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
08809263708607MX 02-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708614MX 02-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708621MX 02-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708638MX 02-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708645MX 02-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708652MX 02-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708720MX 04-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708737MX 04-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708744MX 04-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708751MX 04-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708768MX 04-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708775MX 04-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708843MX 06-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708850MX 06-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708867MX 06-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708874MX 06-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708881MX 06-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708898MX 06-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708904MG 02-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708911MG 02-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708928MG 02-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708935MG 02-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708942MG 02-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708959MG 02-40Meta Biomed Co., Ltd.EKM2026-10-28