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FDA 510(k)

ASTRA TECH IMPLANT DENTAL SYSTEM

K-Number: K974738 · 1998-11-19

ApplicantAstra Tech, Inc.
Decision Date1998-11-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ASTRA TECH IMPLANT DENTAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Astra Tech, Inc.. It received FDA 510(k) clearance on 1998-11-19 under 510(k) number K974738. 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 TECH IMPLANT DENTAL SYSTEM?

ASTRA TECH IMPLANT DENTAL SYSTEM is a medical device that received FDA 510(k) clearance on 1998-11-19. The listed applicant is Astra Tech, Inc.. The 510(k) number is K974738.

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

ASTRA TECH IMPLANT DENTAL SYSTEM received FDA 510(k) clearance on 1998-11-19, under 510(k) number K974738.

Who is the listed applicant for ASTRA TECH IMPLANT DENTAL SYSTEM?

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

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

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

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Other records listing Astra Tech, Inc. 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.

K122078LOFRIC PRIMO, LOFRIC HYDRO-KITK120338ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIAK113003ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...K112138ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANTK110356ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENTK110640ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT

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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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