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FDA 510(k)

ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT

K-Number: K103759 · 2011-04-08

ApplicantAstra Tech, Inc.
Decision Date2011-04-08
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT 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 2011-04-08 under 510(k) number K103759. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT?

ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT is a medical device that received FDA 510(k) clearance on 2011-04-08. The listed applicant is Astra Tech, Inc.. The 510(k) number is K103759.

When did ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT receive FDA 510(k) clearance?

ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT received FDA 510(k) clearance on 2011-04-08, under 510(k) number K103759.

Who is the listed applicant for ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT?

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 ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT?

The FDA product code for ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT is NHA.

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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: NHA)

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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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