FDA.reportPublic FDA data

AXIOM®

Primary DI
03663394478021
Brand
AXIOM®
Company
ETABLISSEMENTS ANTHOGYR
Model
PXFC_NOT
Device description
XRAY TEMPL. AXIOM BL PX
Published
2023-12-16
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
03663394478021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663394478021036633944780213663394478021

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant x-ray templateA non-sterile device intended to be used by a dentist or a surgeon to radiographically determine the appropriate size of a dental implant to be inserted into the jawbone of a patient prior to dental surgery. It is typically made of a translucent plastic sheet marked with incremented graduations that correspond to the lengths of the implants available. The device is typically available in a set with graduated markings and an individual sheet is placed over the x-ray of the jawbone so that the final selection of implant size can be determined against the depth of bone shown by the x-ray. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
275978864
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663394482325HAND-PIECES / CONTRE-ANGLES47562025-12-17
03663394865371HAND-PIECES / CONTRE-ANGLES1600911-0012025-08-20
03663394170871IMPULSION87M2025-02-13
03663394011242AXIOM®OPB3006C2023-12-20
03663394011297AXIOM®OPB3010L2023-12-20
03663394011341AXIOM®OPB3606C2023-12-20
03663394011365AXIOM®OPB3608C2023-12-20
03663394011372AXIOM®OPB3608L2023-12-20
03663394011396AXIOM®OPB3610L2023-12-20
03663394011464AXIOM®OPB4208C2023-12-20
03663394011495AXIOM®OPB4210L2023-12-20
03663394011501AXIOM®OPB4212L2023-12-20
03663394011518AXIOM®OPB4214L2023-12-20
03663394011525AXIOM®OPB4806C2023-12-20
03663394011532AXIOM®OPB4806L2023-12-20
03663394011549AXIOM®OPB4808C2023-12-20
03663394011570AXIOM®OPB4810L2023-12-20
03663394011587AXIOM®OPB4812L2023-12-20
03663394011594AXIOM®OPB4814L2023-12-20
03663394483797AXIOM®OPB5406C2023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052401N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052418N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052425N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052432N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052517N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052524N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052531N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052548N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052555N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052630N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052647N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052654N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052661N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052678N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052685N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052692N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052708N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052715N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052722N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052739N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052746N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052753N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052760N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052777N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053224N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053255N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053262N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053279N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053286N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01