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FDA 510(k)

CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL

K-Number: K873689 · 1987-10-26

ApplicantDentsply Intl.
Decision Date1987-10-26
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1987-10-26 under 510(k) number K873689. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL?

CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL is a medical device that received FDA 510(k) clearance on 1987-10-26. The listed applicant is Dentsply Intl.. The 510(k) number is K873689.

When did CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL receive FDA 510(k) clearance?

CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL received FDA 510(k) clearance on 1987-10-26, under 510(k) number K873689.

Who is the listed applicant for CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL?

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

What is the FDA product code for CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL?

The FDA product code for CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL is GXP.

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Related Devices (Code: GXP)

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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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