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FDA 510(k)

CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM

K-Number: K011502 · 2001-10-22

ApplicantCrystal-Seal Dental Implants
Decision Date2001-10-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Crystal-Seal Dental Implants. It received FDA 510(k) clearance on 2001-10-22 under 510(k) number K011502. 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 AND CRYSTAL-CARE IMPLANTS SYSTEM?

CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM is a medical device that received FDA 510(k) clearance on 2001-10-22. The listed applicant is Crystal-Seal Dental Implants. The 510(k) number is K011502.

When did CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM receive FDA 510(k) clearance?

CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM received FDA 510(k) clearance on 2001-10-22, under 510(k) number K011502.

Who is the listed applicant for CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM?

The FDA 510(k) record lists Crystal-Seal Dental Implants as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM?

The FDA product code for CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM is DZE.

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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

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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