ETABLISSEMENTS ANTHOGYR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Abutment, Implant, Dental, Endosseous (NHA) (9) Implant, Endosseous, Root-Form (DZE) (1)

Premarket Exempt

Clear

Axiom - 03663394000307 Catalog Number :

Device Description : ANGULATED CONICAL ABUT. 18° H3Providing support for a permanent restoration, indexed

Device Class : 2

Duns Number: 275978864

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Axiom - 03663394000314 Catalog Number :

Device Description : ANGULATED CONICAL ABUT. 30° H3Providing support for a permanent restoration, indexed

Device Class : 2

Duns Number: 275978864

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Axiom - 03663394000321 Catalog Number :

Device Description : ANGULATED CONICAL ABUT. 18° H4Providing support for a permanent restoration, indexed

Device Class : 2

Duns Number: 275978864

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Axiom - 03663394000338 Catalog Number :

Device Description : ANGULATED CONICAL ABUT. 30° H4Providing support for a permanent restoration, indexed

Device Class : 2

Duns Number: 275978864

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Axiom - 03663394000345 Catalog Number :

Device Description : TEMPORARY CAP ANG. Ø4.8Giving the negative shape of the permanent abutment for t TEMPORARY CAP ANG. Ø4.8Giving the negative shape of the permanent abutment for the design and realization by casting (lost wax process) of a dental restoration.

Device Class : 2

Duns Number: 275978864

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Axiom - 03663394000352 Catalog Number : PX46100

Device Description : Axiom implant PX Ø4.6 x 10.0,Replacement of a missing tooth for placement of a d Axiom implant PX Ø4.6 x 10.0,Replacement of a missing tooth for placement of a dental restoration, not usable in the molar area, not recommended in D1 bone

Device Class : 2

Duns Number: 275978864

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Axiom - 03663394000369 Catalog Number :

Device Description : PROTECTING CAP Ø4.8Protecting the abutment

Device Class : 2

Duns Number: 275978864

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Axiom - 03663394000376 Catalog Number :

Device Description : GOLD OVERCASTING CAP PCA Ø4.8Giving the negative shape of the permanent abutment GOLD OVERCASTING CAP PCA Ø4.8Giving the negative shape of the permanent abutment for the design and realization by casting (lost wax process) of a dental restoration.

Device Class : 2

Duns Number: 275978864

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Axiom - 03663394000383 Catalog Number :

Device Description : CONICAL ABUTMENT ROT H2 18°Providing support for a permanent restoration, non in CONICAL ABUTMENT ROT H2 18°Providing support for a permanent restoration, non indexed (rotational)

Device Class : 2

Duns Number: 275978864

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Axiom - 03663394000390 Catalog Number :

Device Description : CONICAL ABUTMENT ROT H2 30°Providing support for a permanent restoration, non in CONICAL ABUTMENT ROT H2 30°Providing support for a permanent restoration, non indexed (rotational)

Device Class : 2

Duns Number: 275978864

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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