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FDA 510(k)

EXPANDED CLAIMES TO OSTEOGEN(R)

K-Number: K881662 · 1988-09-01

ApplicantImpladent
Decision Date1988-09-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent for Some Indications

Device Summary

EXPANDED CLAIMES TO OSTEOGEN(R) is the device name listed in this FDA 510(k) record. The listed applicant is Impladent. It received FDA 510(k) clearance on 1988-09-01 under 510(k) number K881662. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the EXPANDED CLAIMES TO OSTEOGEN(R)?

EXPANDED CLAIMES TO OSTEOGEN(R) is a medical device that received FDA 510(k) clearance on 1988-09-01. The listed applicant is Impladent. The 510(k) number is K881662.

When did EXPANDED CLAIMES TO OSTEOGEN(R) receive FDA 510(k) clearance?

EXPANDED CLAIMES TO OSTEOGEN(R) received FDA 510(k) clearance on 1988-09-01, under 510(k) number K881662.

Who is the listed applicant for EXPANDED CLAIMES TO OSTEOGEN(R)?

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

What is the FDA product code for EXPANDED CLAIMES TO OSTEOGEN(R)?

The FDA product code for EXPANDED CLAIMES TO OSTEOGEN(R) is DZE.

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Other records listing Impladent 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.

K923310OSTEOGEN (HA RESORB)K843398OSTEOGENK812321HYDROXI-FLEX IMPLANTK792663FLEXI-CUP IMPLANT

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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