FDA.report

AXIOM®

Primary DI
03663394484046
Brand
AXIOM®
Company
ETABLISSEMENTS ANTHOGYR
Model
MUNFLEX-ET
Device description
FLEXIBASE MUN Ø4.0
Published
2024-01-05
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

Related Records

Product Codes

CodeName
NHAAbutment, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03663394484046PrimaryGS10

GMDN Terms

TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Device Sizes

TypeValueUnit
Outer Diameter4Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
275978864
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
03663394482325HAND-PIECES / CONTRE-ANGLES47562025-12-17
03663394865371HAND-PIECES / CONTRE-ANGLES1600911-0012025-08-20
03663394170871IMPULSION87M2025-02-13
03663394482332Anthogyr OSTEOTOMEINMODOSTSV2024-07-17
03663394011099TORQCONTROL155012024-03-28
03663394173346Anthogyr UNIVERSAL SURGICAL INSTRUMENTINUSI2024-02-27
03663394482936AXIOM®INBW100XL2024-01-23
03663394484275AXIOM®OPFPSL20-ET2024-01-19
03663394484282AXIOM®OPGS20-ET2024-01-19
03663394484299AXIOM®OPGS36-ET2024-01-19
03663394484305AXIOM®OPGS42-ET2024-01-19
03663394484312AXIOM®OPGS50-ET2024-01-19
03663394484329AXIOM®OPFP20-ET2024-01-19
03663394165532AXIOM®OPFPSL20-52024-01-17
03663394165549AXIOM®OPFP202024-01-17
03663394479288AXIOM®INSETIGM2024-01-17
03663394479295AXIOM®OPFPD202024-01-17
03663394479301AXIOM®OPFPSL20-32024-01-17
03663394479318AXIOM®OPGS202024-01-17
03663394479325AXIOM®OPGS20-42024-01-17

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07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486928RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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