FDA.reportPublic FDA data

A. Titan Instruments

Primary DI
00841685101169
Brand
A. Titan Instruments
Company
A. TITAN INSTRUMENTS, INC.
Model
389.04
Device description
Tissue Punch, cylindrical, 4mm
Published
2023-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841685101169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841685101169008416851011698416851011690841685101169

GMDN Terms#

Term, Definition table
TermDefinition
Dental soft-tissue coring punch, reusableA dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Sometimes referred to as a mucotome, it will typically be designed with a handle at the proximal end for manual operation or for mounting into a dental power tool (e.g., contra-angle low-speed drill handpiece), and have a cylindrical hollow tube-like head with a sharp cutting at the distal end. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
037738874
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841685104207A. Titan InstrumentsRubber Tips2023-01-25
00841685104368A. Titan InstrumentsPowder2023-01-25
00841685111373A. Titan Instruments1000 (KIT)2023-01-25
00841685111571A. Titan InstrumentsK-3632023-01-20
00841685111588A. Titan InstrumentsK-3692023-01-20
00841685103453A. Titan InstrumentsT0652023-01-25
00841685112561A. Titan InstrumentsJAC 1S-2S UL2023-08-09
00841685112523A. Titan InstrumentsAMLB-12023-06-28
00841685112530A. Titan InstrumentsAMLB-22023-06-28
00841685112547A. Titan InstrumentsAMLBL-12023-06-28
00841685112554A. Titan InstrumentsAMLBL-22023-06-28
00841685108724A. Titan InstrumentsMB-12023-01-25
00841685112363A. Titan InstrumentsAMLC-42023-04-05
00841685112370A. Titan InstrumentsAMMC-32023-04-05
00841685112387A. Titan InstrumentsAMMC-72023-04-05
00841685112394A. Titan InstrumentsAMMC-102023-04-05
00841685112400A. Titan InstrumentsAMMC-112023-04-05
00841685112417A. Titan InstrumentsAMMC-122023-04-05
00841685112424A. Titan InstrumentsAMMC-132023-04-05
00841685112431A. Titan InstrumentsAMMC-142023-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000069COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000076COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000083COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000090COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000106COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000113COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001509COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001684COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001691COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001707COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001714COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001721COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001738COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001745COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015315COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015322COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015339COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015346COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015353COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015971COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015988COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000052COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-27
00083208130380Scissors Dean T/C CurvedSuncoast Dental, IncDZN2026-10-07
00816594025448CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
00816594025462CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
00816594025714CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
07908854001750Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
07908854001835Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
07908854018079Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
D955BBGA351Paul BandittTerlain Enterprises, Inc.DZN2026-09-25