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FDA 510(k)

OSTEOMED IB DRILL

K-Number: K911937 · 1991-06-10

ApplicantOsteomed Corp.
Decision Date1991-06-10
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOMED IB DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Corp.. It received FDA 510(k) clearance on 1991-06-10 under 510(k) number K911937. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOMED IB DRILL?

OSTEOMED IB DRILL is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is Osteomed Corp.. The 510(k) number is K911937.

When did OSTEOMED IB DRILL receive FDA 510(k) clearance?

OSTEOMED IB DRILL received FDA 510(k) clearance on 1991-06-10, under 510(k) number K911937.

Who is the listed applicant for OSTEOMED IB DRILL?

The FDA 510(k) record lists Osteomed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSTEOMED IB DRILL?

The FDA product code for OSTEOMED IB DRILL is EFB.

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Other records listing Osteomed Corp. 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.

K022277OSTEOMED CRANIAL FLAP FIXATION SYSTEMK022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK022886METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK0232601.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEMK013618INTRAORAL MANDIBULAR DISTRACTION SYSTEMK021618OSA RIGID INTERNAL FIXATION SYSTEM

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Related Devices (Code: EFB)

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.

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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