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FDA 510(k)

SERIES I AND II IMPLANTS

K-Number: K882226 · 1988-08-29

ApplicantSaber Technology, Inc.
Decision Date1988-08-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SERIES I AND II IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Saber Technology, Inc.. It received FDA 510(k) clearance on 1988-08-29 under 510(k) number K882226. 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 SERIES I AND II IMPLANTS?

SERIES I AND II IMPLANTS is a medical device that received FDA 510(k) clearance on 1988-08-29. The listed applicant is Saber Technology, Inc.. The 510(k) number is K882226.

When did SERIES I AND II IMPLANTS receive FDA 510(k) clearance?

SERIES I AND II IMPLANTS received FDA 510(k) clearance on 1988-08-29, under 510(k) number K882226.

Who is the listed applicant for SERIES I AND II IMPLANTS?

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

What is the FDA product code for SERIES I AND II IMPLANTS?

The FDA product code for SERIES I AND II IMPLANTS is DZE.

Related Clinical Trials

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.

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Other records listing Saber Technology, 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.

K924112HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II

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

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

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