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orangedental GmbH & Co. KG

Active in EUDAMED

Germanyfrom SRN EUDAMED SRN DE-MF-000006152

Devices
8
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate

What orangedental GmbH & Co. KG makes

orangedental GmbH & Co. KG manufactures reusable dental drill bits and related fixtures, including cordless and ergonomic designs like the spot-on cordfree, SUNIRAY 5.2, and byzz nxt series. Their portfolio also includes precision drill tips such as the opt-on 3.3 and opt-on 2.7, as well as reusable and sterilizable single-use tips like the pa-on Einmalspitzen sterilisierbar. Additional tools include the pa-on parometer for diagnostic measurements.

These devices are classified under Class I and Class II regulations, with listings in the EU’s eudamed registry and the FDA’s 510(k) clearance system. The company is based in Germany.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue8

Newest first, rows 1-8 of 8

  • spot-on cordfree Ref 4260375690718 / lup0499200

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Suniray 5.2 Ref K072665

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • opt-on 3.3 Ref 4260375690107 / lup0499100

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • byzz nxt Ref 04260375690732

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • spot-on nxt Ref 4260375690138 / lup0499110

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • pa-on parometer Ref 04260375690015

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • pa-on Einmalspitzen sterilisierbar Ref zubpaon0492000

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • opt-on 2.7 Ref 4260375690091 / lup0499000

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Company details

EUDAMED SRN
DE-MF-000006152
EU VAT number
DE813836850
EUDAMED status
Active
EUDAMED registered name
orangedental GmbH & Co. KG
EUDAMED abbreviated name
OD
Registered address
11, Aspachstraße, 88400, Biberach a.d. Riß, Germany
Phone
497351474990(from company website)
PRRC contact
Jonathan Fischer(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 23 Sep 2031

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 735418 Active

    Quality management system EU MDR

    Issued
    24 Sep 2026
    Expires
    23 Sep 2031

From the company website

Read 18 Oct 2026

Exciting lectures with high-calibre speakers await you: From digital workflows, artificial intelligence, dental imaging with 3D X-rays and MRI diagnostics, periodontology and ergonomic work to new materials, almost the entire dental spectrum is offered. Experience the latest orangedental products and digital workflows and learn about our innovative training concepts.

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does orangedental GmbH & Co. KG have in the registry?

The registry currently lists 8 devices for orangedental GmbH & Co. KG. Devices recorded under merged duplicate company entries are counted once.

Which registries list orangedental GmbH & Co. KG's devices?

Among its 8 most recently registered devices, orangedental GmbH & Co. KG has devices listed in EUDAMED (7 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do orangedental GmbH & Co. KG's devices fall under?

Among its 8 most recently registered devices, the classes recorded for orangedental GmbH & Co. KG's devices are Class I and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for orangedental GmbH & Co. KG?

EUDAMED lists 1 certificate for orangedental GmbH & Co. KG (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 24 Sep 2026.

What are the newest devices from orangedental GmbH & Co. KG in the registry?

The most recently registered devices listed for orangedental GmbH & Co. KG include spot-on cordfree, SUNIRAY 5.2, opt-on 3.3 and byzz nxt.

Generated automatically from registry data and not verified by a human reviewer.