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FDA 510(k)

INTRAOSSEOUS DENTAL IMPLANT

K-Number: K813227 · 1981-12-31

ApplicantPacific Implant, Inc.
Decision Date1981-12-31
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTRAOSSEOUS DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Implant, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813227. 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 INTRAOSSEOUS DENTAL IMPLANT?

INTRAOSSEOUS DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Pacific Implant, Inc.. The 510(k) number is K813227.

When did INTRAOSSEOUS DENTAL IMPLANT receive FDA 510(k) clearance?

INTRAOSSEOUS DENTAL IMPLANT received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813227.

Who is the listed applicant for INTRAOSSEOUS DENTAL IMPLANT?

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

What is the FDA product code for INTRAOSSEOUS DENTAL IMPLANT?

The FDA product code for INTRAOSSEOUS DENTAL IMPLANT 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 Pacific Implant, 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.

K992582PACIFIC IMPLANT TITANIUM ENDODONTIC POINT

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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