FDA.reportPublic FDA data

T6 Driver Bit 1PK, Latch Type

Primary DI
D990TDBT61PKLT0
Brand
T6 Driver Bit 1PK, Latch Type
Company
SMART DENTURE CONVERSIONS, LLC
Model
TDB-T61PK-LT
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D990TDBT61PKLT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8555500707contact@smartdentureconversions.com

Regulatory Flags#

DUNS number
010613514
Device count
1
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D990EK2A0Essentials Kit, 2 ArchEK2A2026-07-13
D99025HMINIOA0Omnibut, Hiossen Mini, 2.5GH25HMINI-OA2026-06-26
D99025HMINIOA140Omnibut, Hiossen Mini, 2.5GH, M1.425HMINI-OA1.42026-06-26
D99025HREGOA0Omnibut, Hiossen Regular, 2.5GH25HREG-OA2026-06-26
D99025HREGOA140Omnibut, Hiossen Regular, 2.5GH, M1.425HREG-OA1.42026-06-26
D99025MGAOA0Omnibut, MegaGen AnyRidge, 2.5GH25MGA-OA2026-06-26
D99025MGAOA140Omnibut, MegaGen AnyRidge, 2.5GH, M1.425MGA-OA1.42026-06-26
D99025TINT37OA0Omnibut, Tatum Integrity 3.7, 2.5GH25TINT37-OA2026-06-26
D99025TINT37OA140Omnibut, Tatum Integrity 3.7, 2.5GH, M1.425TINT37-OA1.42026-06-26
D99025TINT50OA0Omnibut, Tatum Integrity 5.0, 2.5GH25TINT50-OA2026-06-26
D99025TINT50OA140Omnibut, Tatum Integrity 5.0, 2.5GH, M1.425TINT50-OA1.42026-06-26
D99025TINT60OA0Omnibut, Tatum Integrity 6.0, 2.5GH25TINT60-OA2026-06-26
D99025TINT60OA140Omnibut, Tatum Integrity 6.0, 2.5GH, M1.425TINT60-OA1.42026-06-26
D99038BLXOA0Omnibut, Straumann BLX, 3.8GH38BLX-OA2026-06-26
D99038BLXOA140Omnibut, Straumann BLX, 3.8GH, M1.438BLX-OA1.42026-06-26
D99038HMINIOA0Omnibut, Hiossen Mini, 3.8GH38HMINI-OA2026-06-26
D99038HMINIOA140Omnibut, Hiossen Mini, 3.8GH, M1.438HMINI-OA1.42026-06-26
D99038HREGOA0Omnibut, Hiossen Regular, 3.8GH38HREG-OA2026-06-26
D99038HREGOA140Omnibut, Hiossen Regular, 3.8GH, M1.438HREG-OA1.42026-06-26
D99038IH35OA0Omnibut, Internal Hex 3.5, 3.8GH38IH35-OA2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14