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FDA 510(k)

APACERAM ARTIFICIAL DENTAL IMPLANT

K-Number: K885133 · 1989-09-05

ApplicantAsahi Optical Co. C/O Rosati Associates, P.C.
Decision Date1989-09-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

APACERAM ARTIFICIAL DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Optical Co. C/O Rosati Associates, P.C.. It received FDA 510(k) clearance on 1989-09-05 under 510(k) number K885133. 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 APACERAM ARTIFICIAL DENTAL IMPLANT?

APACERAM ARTIFICIAL DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1989-09-05. The listed applicant is Asahi Optical Co. C/O Rosati Associates, P.C.. The 510(k) number is K885133.

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

APACERAM ARTIFICIAL DENTAL IMPLANT received FDA 510(k) clearance on 1989-09-05, under 510(k) number K885133.

Who is the listed applicant for APACERAM ARTIFICIAL DENTAL IMPLANT?

The FDA 510(k) record lists Asahi Optical Co. C/O Rosati Associates, P.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APACERAM ARTIFICIAL DENTAL IMPLANT?

The FDA product code for APACERAM ARTIFICIAL 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 Asahi Optical Co. C/O Rosati Associates, P.C. 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.

K893134APACERAM OSSICULAR PROSTHESISK872089APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G)K861960ZIMLITE LENS

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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