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FDA 510(k)

CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM

K-Number: K954432 · 1996-07-24

ApplicantCrystal Medical Technology
Decision Date1996-07-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Crystal Medical Technology. It received FDA 510(k) clearance on 1996-07-24 under 510(k) number K954432. 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 CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM?

CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM is a medical device that received FDA 510(k) clearance on 1996-07-24. The listed applicant is Crystal Medical Technology. The 510(k) number is K954432.

When did CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM receive FDA 510(k) clearance?

CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM received FDA 510(k) clearance on 1996-07-24, under 510(k) number K954432.

Who is the listed applicant for CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM?

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

What is the FDA product code for CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM?

The FDA product code for CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM 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 Crystal Medical Technology 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.

K980442CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM

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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