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FDA 510(k)

IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM

K-Number: K973049 · 1997-11-13

ApplicantImcor
Decision Date1997-11-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Imcor. It received FDA 510(k) clearance on 1997-11-13 under 510(k) number K973049. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM?

IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-13. The listed applicant is Imcor. The 510(k) number is K973049.

When did IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM receive FDA 510(k) clearance?

IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM received FDA 510(k) clearance on 1997-11-13, under 510(k) number K973049.

Who is the listed applicant for IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM?

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

What is the FDA product code for IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM?

The FDA product code for IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM is DZE.

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Other records listing Imcor 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.

K992512ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COAK983563IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND IK982492IMCOR DENTAL IMPLANT SYSTEM ACCESSORIESK974126IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREWK960899IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREWK960900IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW

View all 7 devices →

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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