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Anthogyr Axiom® BL 2.8 Dental Implant System - HSA Registration DE0505387

Access comprehensive regulatory information for Anthogyr Axiom® BL 2.8 Dental Implant System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505387 and owned by Anthogyr. The device was registered on January 25, 2021.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0505387
Anthogyr Axiom® BL 2.8 Dental Implant System
HSA Registration Number: DE0505387
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Product Description

Axiom® BL 2.8 implants are intended for oral implantation to replace missing tooth roots, and to provide support for dental restoration. Axiom® BL 2.8 implants can be used in one-stage or two-stage surgeries to restore the function of a missing tooth. They are indicated for single replacement of mandibular incisors and lateral maxillary incisors in cases presenting a restricted mesiodistal space.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0505387
Registration Date
January 25, 2021
Change Notification Approval Date
March 11, 2025
Retention Due Date
January 24, 2026
Product Owner
Short Name
Anthogyr
Address
2237 avenue Andre Lasquin, 74700, SALLANCHES, FRANCE
Registrant
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #19-05, SINGAPORE 179101
Importer
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #19-05, SINGAPORE 179101
Model Information
Model Name(s)
AUTOMATIC MICRO IMPACTOR MANDREL EXTENSION ROUND BUR Ø2.0 AXIOM Ø2.8 SURGERY MODUL AXIOM IMPLANT Ø2.8 x 10.0 AXIOM IMPLANT Ø2.8 x 12.0 AXIOM IMPLANT Ø2.8 x 14.0 IMPACTED ABUTMENT 0° H1 IMPACTED ABUTMENT 7° H1 IMPACTED ABUTMENT 15° H1 IMPACTED ABUTMENT 23° H1 IMPACTED ABUTMENT 0° H2.5 IMPACTED ABUTMENT 7° H2.5 IMPACTED ABUTMENT 15° H2.5 IMPACTED ABUTMENT 23° H2.5 IMPACTED ABUTMENT 0° H4.0 IMPACTED ABUTMENT 7° H4.0 IMPACTED ABUTMENT 15° H4.0 IMPACTED ABUTMENT 23° H4.0 IMPACTED ABUTMENT 0° H5.5 IMPACTED ABUTMENT 7° H5.5 IMPACTED ABUTMENT 15° H5.5 IMPACTED ABUTMENT 23° H5.5 TWIST DRILL AXIOM Ø2.6 x 25 PILOT DRILL Ø2.0x 25.0 HEALING PLUG H1 HEALING PLUG H2.5 HEALING PLUG H4.0 HEALING PLUG H5.5 COVER PLUG ABUTMENT IMPACTION PART ANGULATED IMPACTION PART PROSTHETIC IMPACTION PART MANDREL AXIOM Ø2.8 PROTECTING CAP POINTER DRILL Ø1.5 AXIOM TAP Ø2.8 x 25 TEMPORARY ABUTMENT H1 TEMPORARY ABUTMENT H2.5 TEMPORARY ABUTMENT H4.0 TEMPORARY ABUTMENT H5.0
Model Identifier(s)
6920 INEXM INFB20 INMODOP28 OP28100 OP28120 OP28140 OPAT210 OPAT211 OPAT212 OPAT213 OPAT220 OPAT221 OPAT222 OPAT223 OPAT240 OPAT241 OPAT242 OPAT243 OPAT250 OPAT251 OPAT252 OPAT253 OPFE26250 OPFI20250 OPHS210 OPHS220 OPHS240 OPHS250 OPIM028 OPIP100 OPIP200 OPIP400 OPMV028 OPPC028 OPPO15150 OPTA28250 OPTP210 OPTP220 OPTP240 OPTP250