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FDA 510(k)

ASTRA DENTAL IMPLANT SYSTEM

K-Number: K882578 · 1988-08-12

ApplicantAstra Meditec AB
Decision Date1988-08-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ASTRA DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Astra Meditec AB. It received FDA 510(k) clearance on 1988-08-12 under 510(k) number K882578. 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 ASTRA DENTAL IMPLANT SYSTEM?

ASTRA DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1988-08-12. The listed applicant is Astra Meditec AB. The 510(k) number is K882578.

When did ASTRA DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

ASTRA DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 1988-08-12, under 510(k) number K882578.

Who is the listed applicant for ASTRA DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for ASTRA DENTAL IMPLANT SYSTEM?

The FDA product code for ASTRA DENTAL IMPLANT SYSTEM is DZE.

Related Clinical Trials

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Other records listing Astra Meditec AB 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.

K920819ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAINK896750LOFRIC(R), LOFRIC(R) CATH-KIT

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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