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FDA 510(k)

3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION

K-Number: K935544 · 1995-03-13

ApplicantImplant Innovations International, Inc.
Decision Date1995-03-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Implant Innovations International, Inc.. It received FDA 510(k) clearance on 1995-03-13 under 510(k) number K935544. 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 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION?

3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION is a medical device that received FDA 510(k) clearance on 1995-03-13. The listed applicant is Implant Innovations International, Inc.. The 510(k) number is K935544.

When did 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION receive FDA 510(k) clearance?

3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION received FDA 510(k) clearance on 1995-03-13, under 510(k) number K935544.

Who is the listed applicant for 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION?

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

What is the FDA product code for 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION?

The FDA product code for 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION is DZE.

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Other records listing Implant Innovations International, 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.

K932123IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEMK911655IMPLARETTEK905303ABUTMENT GLOK911701G-FLOSS & G-FLOSS IIK891613OVERDENTURE ATTACHMENTK891612DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.

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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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