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Absoanchor Microimplant

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K060126Ref ST-LRef ED26-SRef ED17-LRef NHCDRef LHD-B+DT-SRef NLHDRef ST-SRef LHD-B+DT-LRef ED17-SRef DT-SRef ED36-SRef SHD-SRef HCDRef ED19-SRef ED36-LRef NLHD-S+ST-SRef ED26-L

by DENTOS Inc.

Identity

Trade Name
AbsoAnchor EUDAMED
Orthodontic Driver FDA UDI
Generic Name
Surgical screwdriver, reusable FDA UDI
Device Name
Driver EUDAMED
Model / Reference
NLHD-S+ST-S EUDAMEDFDA UDI
ST-S EUDAMEDFDA UDI
ED19-S EUDAMEDFDA UDI
ED36-S EUDAMEDFDA UDI
ED17-L EUDAMEDFDA UDI
ED26-S EUDAMEDFDA UDI
LHD-B+DT-L EUDAMEDFDA UDI
NLHD EUDAMEDFDA UDI
ED17-S EUDAMEDFDA UDI
ED36-L EUDAMEDFDA UDI
ST-L EUDAMEDFDA UDI
DT-S EUDAMEDFDA UDI
ED26-L EUDAMEDFDA UDI
LHD-B+DT-S EUDAMEDFDA UDI
SHD-S EUDAMEDFDA UDI
HCD EUDAMEDFDA UDI
NHCD EUDAMED

Identifiers

Primary DI / UDI-DI
08806145440174 EUDAMEDFDA UDI
08806145435132 EUDAMEDFDA UDI
08806145435170 EUDAMEDFDA UDI
08806145435224 EUDAMEDFDA UDI
08806145435156 EUDAMEDFDA UDI
08806145435200 EUDAMEDFDA UDI
08806145440129 EUDAMEDFDA UDI
08806145435019 EUDAMEDFDA UDI
08806145435163 EUDAMEDFDA UDI
08806145435217 EUDAMEDFDA UDI
08806145435149 EUDAMEDFDA UDI
08806145435125 EUDAMEDFDA UDI
08806145435194 EUDAMEDFDA UDI
08806145440136 EUDAMEDFDA UDI
08806145435255 EUDAMEDFDA UDI
08806145435279 EUDAMEDFDA UDI
08806145477767 EUDAMED
Basic UDI-DI
88061454AD001D5 EUDAMED
510(k) Number
K060126 FDA 510(k)
FDA Product Code
DZE FDA 510(k)
ECT FDA UDI
EMDN Code
Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
GMDN Term
Surgical screwdriver, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 FDA 510(k)
872.4565 FDA UDI
Market of Registration
Poland EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

The AbsorAnchor Microimplant is a dental microimplant designed for orthodontic anchorage, classified under the product code DZE. This device is intended for temporary skeletal anchorage in orthodontic treatment, providing stable fixation points for tooth movement without relying on patient cooperation.

Supplied as a single-use, sterile device, the AbsorAnchor Microimplant is intended for use in orthodontic clinics. It is regulated under FDA 510K clearance (K060126) and meets the requirements of the EU Medical Device Regulation (MDR). The device is non-magnetic and compatible with MRI environments, though its use should follow standard orthodontic protocols for patient safety and efficacy.

Frequently asked questions

What is the AbsorAnchor Microimplant primarily used for in orthodontic treatment?

The AbsorAnchor Microimplant is designed specifically for temporary skeletal anchorage in orthodontics. It provides stable fixation points to facilitate controlled tooth movement without depending on patient cooperation, such as wearing elastics or headgear. This makes it ideal for complex cases where traditional anchorage methods may be unreliable.

Is the AbsorAnchor Microimplant intended for reuse, or is it single-use only?

The AbsorAnchor Microimplant is supplied as a single-use, sterile device, meaning each implant is intended for one patient only. This design ensures infection control and maintains the device’s integrity for optimal performance in orthodontic anchorage.

Can the AbsorAnchor Microimplant be used in patients who require MRI scans?

Yes, the AbsorAnchor Microimplant is non-magnetic, making it compatible with MRI environments. However, as with any orthodontic hardware, standard safety protocols for orthodontic treatment should still be followed to ensure patient safety and treatment efficacy during and after MRI procedures.

How is the AbsorAnchor Microimplant regulated, and what does that mean for clinicians?

The AbsorAnchor Microimplant is regulated under FDA 510(k) clearance (K060126) and complies with the EU Medical Device Regulation (MDR). The FDA’s clearance under product code DZE (Dental, Orthodontic Anchorage Devices) confirms it meets U.S. safety and performance standards for its intended use. Clinicians can rely on this regulatory pathway to ensure the device adheres to established orthodontic anchorage requirements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
DENTOS Inc.
FDA Applicant
Dentos, Inc.

Sources (34)

  • FDA 510(k) K060126 24 fields · synced Sep 18, 2026
  • FDA UDI 7834afaa-75bc-44cd-9b4f-3de8056bdf19 32 fields · synced May 24, 2026
  • FDA UDI 8b60d03c-18a3-4c59-9b6e-8ffd899d06b3 32 fields · synced May 27, 2026
  • FDA UDI c545ea4d-eb69-4cc6-b614-de4a6ca87d02 32 fields · synced May 29, 2026
  • FDA UDI 46eeda1a-8b82-4281-8e43-bd7435832fa4 32 fields · synced May 29, 2026
  • FDA UDI cacc1353-424b-42a7-81b0-ba0bd17fcf2e 32 fields · synced May 30, 2026
  • FDA UDI b4dc0a1f-f8b6-42c0-875b-a246863188c5 32 fields · synced May 30, 2026
  • FDA UDI 1edd85ba-95f3-4f79-9e99-8ef88bd6407a 32 fields · synced May 30, 2026
  • FDA UDI bd58f007-4fa6-4c7b-8cd9-f5f8e6625b97 32 fields · synced May 30, 2026
  • FDA UDI 800d078b-3b49-4ae7-b38e-dddddf31be6e 32 fields · synced May 30, 2026
  • FDA UDI ed5d03c4-942b-4940-a67c-560142c068e2 32 fields · synced May 30, 2026
  • FDA UDI e5d392f6-d5be-4a73-84ed-6e02cedd2277 32 fields · synced May 30, 2026
  • FDA UDI 1c2b1bae-3cbf-4080-b32b-f3dd70fbe8c2 32 fields · synced May 30, 2026
  • FDA UDI 104e874d-48d2-46a3-8d94-c6d20a6ccf87 32 fields · synced May 30, 2026
  • FDA UDI e6492b4f-544b-49b3-9c4d-eb335594e37d 32 fields · synced May 30, 2026
  • FDA UDI c728f7dd-c18f-46d7-9fc8-aabfb8db067e 32 fields · synced May 30, 2026
  • FDA UDI 25c63173-8b33-4adc-a4b0-92dbc3ca885f 32 fields · synced May 30, 2026
  • EUDAMED d4efb7a3-9995-4b8a-a884-3d48244b8f44 61 fields · synced Jul 9, 2026
  • EUDAMED 4b8b4b24-23a5-4a7f-8945-678a24f62a6a 61 fields · synced Jul 9, 2026
  • EUDAMED db3ee476-793f-4df6-851d-684afed8c53a 61 fields · synced Jul 9, 2026
  • EUDAMED efed9bd8-a84a-4cd5-9a68-afdbf1cee92e 61 fields · synced Jul 9, 2026
  • EUDAMED 50b27fd8-2742-41ed-b3a5-7d3efae2f601 61 fields · synced Jul 9, 2026
  • EUDAMED f70f7613-6caa-4afa-9786-7ae10cce9eaf 61 fields · synced Jul 9, 2026
  • EUDAMED 141c038e-5ac7-4b9e-b7e3-37d0974cdcb7 61 fields · synced Jul 9, 2026
  • EUDAMED 73ed2e54-975c-4e30-9f56-9445635812d9 61 fields · synced Jul 14, 2026
  • EUDAMED 773795a9-ebfb-4f91-9cb5-6b020deeb64d 61 fields · synced Jul 14, 2026
  • EUDAMED 20363bf9-5702-4307-964b-b745364b80c6 61 fields · synced Jul 15, 2026
  • EUDAMED 7b1f9dcd-8815-4571-8c2a-3d76e39345d7 61 fields · synced Jul 17, 2026
  • EUDAMED abc2e28c-3039-4062-9710-3f08e3eda9ae 61 fields · synced Jul 26, 2026
  • EUDAMED 66857ecb-c6e0-48ac-ade3-189086a11e44 61 fields · synced Jul 30, 2026
  • EUDAMED 4a24cba3-9fb5-4c1e-a507-845625977ef0 61 fields · synced Aug 1, 2026
  • EUDAMED c4714868-c9f7-434b-aed0-543bda3a300c 61 fields · synced Aug 2, 2026
  • EUDAMED 43bdf0be-6b50-4cf5-b470-d0971ea845ef 61 fields · synced Sep 17, 2026
  • EUDAMED 058ea058-5a8c-4b8b-883a-b15ca4bc6645 61 fields · synced Sep 18, 2026