FDA.reportPublic FDA data

Angulated Screwdriver

Primary DI
07540204000152
Brand
Angulated Screwdriver
Company
Panthera Dentaire Inc
Model
0.048 20mm
Catalog number
34020
Device description
"Reusable dental tool made of phynox and adapted to screw a Panthera Dental angulated screw channel device on an endo-osseous dental implant. It is intended to be used with the following screw patterns: Unigrip, 0.050"""
Published
2025-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07540204000152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540204000152075402040001527540204000152

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

Regulatory Flags#

DUNS number
203254607
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540204000299Panthera D-Guide Single sided12026-04-06
07540204000305Panthera D-Guide Double sided12026-04-06
07540204000275Panthera D-SAD Classic Duo12025-11-28
07540204000282Panthera D-SAD X3 Duo12025-11-28
07540204000022The Panthera Anti-Snoring X3 Device12018-05-10
07540204000091Angulated Screwdriver Unigrip 30mm340142025-01-09
07540204000107Angulated Screwdriver 0.050 30mm340152025-01-09
07540204000114Angulated Screwdriver 0.048 30mm340162025-01-09
07540204000121Angulated Screwdriver KCS 30mm340172025-01-09
07540204000138Angulated Screwdriver Unigrip 20mm340182025-01-09
07540204000145Angulated Screwdriver 0.050 20mm340192025-01-09
07540204000169Angulated Screwdriver KCS 20mm340212025-01-09
07540204000046Panthera Dental Milled Bar12024-10-28
07540204000053The Panthera Anti-Snoring Device12024-10-28
07540204000060Panthera D-SAD X312024-10-28
07540204000077Panthera Occlusal Appliance - Single12024-10-28
07540204000015The Panthera Anti-Snoring Device12016-09-23
07540204000039Panthera Dental Milled Bar12018-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235565DRIVER RATCHET RETRIVER M1.6MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
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