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FDA 510(k)

KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS

K-Number: K961381 · 1997-09-09

ApplicantThe Emerging Technologies Group
Decision Date1997-09-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS is the device name listed in this FDA 510(k) record. The listed applicant is The Emerging Technologies Group. It received FDA 510(k) clearance on 1997-09-09 under 510(k) number K961381. 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 KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS?

KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS is a medical device that received FDA 510(k) clearance on 1997-09-09. The listed applicant is The Emerging Technologies Group. The 510(k) number is K961381.

When did KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS receive FDA 510(k) clearance?

KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS received FDA 510(k) clearance on 1997-09-09, under 510(k) number K961381.

Who is the listed applicant for KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS?

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

What is the FDA product code for KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS?

The FDA product code for KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS is DZE.

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Other records listing The Emerging Technologies Group 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.

K961382MT1AK961387MT-XK961383MT1K961385MT-3AK961386MT-2AK961384MT-2

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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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