Skip to content

The Straumann Company

Also registered as The Straumann Co.

Country not established

Devices
15
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue15

Newest first, rows 1-15 of 15

Search and filter all 15 devices
Skip device list

  • Iti Distance System Ref K931993

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

  • Pre-Sterilized Iti Dental Implants Ref K920928

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

  • Memfix Ref K955369

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

  • Plastic Protection Healing Caps Ref K962023

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

  • Endosseous Dental Implant & Accessories Ref K955281

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

  • Iti Angled Abutment Ref K941393

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

  • Hollow Screw Implants 6mm, 14mm, 16mm Ref K920768

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

  • Modus Sagittal Split Plate Ref K993862

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

  • Iti Transversal Screwing System Ref K943720

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

  • Bone Marrow Biopsy System Ref K923872

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

  • The Straumann Ortho Implant System Ref K040469

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

  • Straumann Temporary Coping Ref K041070

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

  • Titanium Healing Caps Ref K960634

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

  • Straumann Granules Ref K040646

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

  • Straumann Emdogain Ref P930021 Open recall

    Active Regimes: PMA Registry: PMA Class:III

Rows 1-15 of 15

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2004

    • 11 Nov 2004 Z-0300-05 Unclassified (pre-2012) Terminated Outside label incorrectly identifes drill as Regular Neck (RN) instead of Wide Neck (WN) Distribution: Nationwide
    • 21 May 2004 Z-1035-04 Unclassified (pre-2012) Terminated Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN) Distribution: Nationwide. AL, AZ, CA, DE, FL, IA, MA, MI. MD, NC, NE, NY, NJ, TX

Frequently asked questions

How many devices does The Straumann Company have in the registry?

The registry currently lists 15 devices for The Straumann Company. Devices recorded under merged duplicate company entries are counted once.

Which registries list The Straumann Company's devices?

Among its 15 most recently registered devices, The Straumann Company has devices listed in FDA 510(k) (14 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do The Straumann Company's devices fall under?

Among its 15 most recently registered devices, the classes recorded for The Straumann Company's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for The Straumann Company?

FDA recall records list 2 recalls initiated by The Straumann Company, the most recent initiated on 11 Nov 2004. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from The Straumann Company in the registry?

The most recently registered devices listed for The Straumann Company include ITI DISTANCE SYSTEM, PRE-STERILIZED ITI DENTAL IMPLANTS, MEMFIX and PLASTIC PROTECTION HEALING CAPS.

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