FDA.reportPublic FDA data

Tools

Primary DI
17290107275689
Brand
Tools
Company
A.B. DENTAL DEVICES LTD
Model
TDCSt-2.2,11.5
Catalog number
TDCSt-2.2,11.5
Device description
Conical Stopper Drill Bit
Published
2019-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290107275689PackageGS110In Commercial Distribution
07290107275682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010727568917290107275689
07290107275682072901072756827290107275682

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+972732454900Info@ab-dent.com

Regulatory Flags#

DUNS number
534128491
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290107270052Titan ImplantsI2-3.75,8I2-3.75,82024-11-19
07290107270106Titan ImplantsI2-4.2,8I2-4.2,82024-11-19
07290107270151Titan ImplantsI2-4.2,18I2-4.2,182024-11-19
07290107270274Titan ImplantsI2-6,8I2-6,82024-11-19
07290107270281Titan ImplantsI2-6,10I2-6,102024-11-19
07290107270298Titan ImplantsI2-6,11.5I2-6,11.52024-11-19
07290107270502Titan ImplantsI5-4.5,6I5-4.5,62024-11-19
07290107270564Titan ImplantsI5-5,6I5-5,62024-11-19
07290107270625Titan ImplantsI5-6,6I5-6,62024-11-19
07290107270793Titan ImplantsI6-2.4,13I6-2.4,132024-11-19
07290107270823Titan ImplantsI6-3,10I6-3,102024-11-19
07290107270830Titan ImplantsI6-3,11.5I6-3,11.52024-11-19
07290107270847Titan ImplantsI6-3,16I6-3,162024-11-19
07290107270854Titan ImplantsI6-3,13I6-3,132024-11-19
07290107270878Titan ImplantsI6-3.2,11.5I6-3.2,11.52024-11-19
07290107270885Titan ImplantsI6-3.2,13I6-3.2,132024-11-19
07290107270908Titan ImplantsI6b-2.4,11.5I6b-2.4,11.52024-11-19
07290107270915Titan ImplantsI6b-2.4,13I6b-2.4,132024-11-19
07290107271189Titan ImplantsI10-4.2,8I10-4.2,82024-11-19
07290107271226Titan ImplantsI10-4.2,16I10-4.2,162024-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMKA03117ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA10503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA20503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA40503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA02821ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA10502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA20502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA40502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8509ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851517ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851530ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8515TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS81PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS82PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS83PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC83ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11