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FDA 510(k)

TISSUE INTEGRATED PROSTHESIS DRILL

K-Number: K841813 · 1984-08-10

ApplicantBofors Nobelpharma, Inc.
Decision Date1984-08-10
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TISSUE INTEGRATED PROSTHESIS DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Bofors Nobelpharma, Inc.. It received FDA 510(k) clearance on 1984-08-10 under 510(k) number K841813. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TISSUE INTEGRATED PROSTHESIS DRILL?

TISSUE INTEGRATED PROSTHESIS DRILL is a medical device that received FDA 510(k) clearance on 1984-08-10. The listed applicant is Bofors Nobelpharma, Inc.. The 510(k) number is K841813.

When did TISSUE INTEGRATED PROSTHESIS DRILL receive FDA 510(k) clearance?

TISSUE INTEGRATED PROSTHESIS DRILL received FDA 510(k) clearance on 1984-08-10, under 510(k) number K841813.

Who is the listed applicant for TISSUE INTEGRATED PROSTHESIS DRILL?

The FDA 510(k) record lists Bofors Nobelpharma, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TISSUE INTEGRATED PROSTHESIS DRILL?

The FDA product code for TISSUE INTEGRATED PROSTHESIS DRILL is ERL.

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Other records listing Bofors Nobelpharma, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K841551OSSEOINTEGRATED FIXTURES-TISSUE INTEGRK820013TITANIUM IMPLANT DEVICES

Related Devices (Code: ERL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

Official Source

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