Astra Tech Implants - Dental System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K002513 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in Zirconia

  Class II

  FDA 510(k) K120338 Active Cleared 5 Jul 2012

• Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants, Atlantis Gemini + Abutment for Nobel

  Class II

  FDA 510(k) K091920 Active Cleared 28 Sep 2009

• Osseospeed Tm Profile System

  Class II

  FDA 510(k) K080156 Active Cleared 17 Sep 2008

• Modification To: Lofric Plus Single Use Urinary Catheter

  Class II

  FDA 510(k) K012374 Active Cleared 23 Aug 2001

• Modification to Astra Tech Implant - Dental System

  Class II

  FDA 510(k) K990304 Active Cleared 15 Jul 1999

• Atlantis Crown Abutment, Atlantis Gemini +(Tm) Abutment

  Class II

  FDA 510(k) K110356 Active Cleared 10 Jun 2011

See all devices from Astra Tech, Inc. →

• What is the ASTRA TECH IMPLANTS - DENTAL SYSTEM used for?

  The ASTRA TECH IMPLANTS - DENTAL SYSTEM is a dental implant system used for dental implantation procedures, as stated in the device description. It is intended to support prosthetic teeth in the jawbone through surgical placement.

• How is the ASTRA TECH IMPLANTS - DENTAL SYSTEM supplied and by whom?

  The device is supplied by Astra Tech, Inc., located at 430 Bedford St., Suite 100, Lexington, MA 02173, as indicated in the manufacturer and address fields of the device data.

• What regulatory pathway was used for the ASTRA TECH IMPLANTS - DENTAL SYSTEM?

  The device received FDA 510(k) clearance under K002513, as specified in the AUTHORIZATIONS and k_number fields, and was determined to be substantially equivalent to a predicate device.

• What product code classifies the ASTRA TECH IMPLANTS - DENTAL SYSTEM?

  The device is classified under product code DZE, as explicitly listed in the product_code field, which corresponds to its categorization in the FDA’s product code system for dental devices.

• When was the ASTRA TECH IMPLANTS - DENTAL SYSTEM cleared by the FDA?

  The device received FDA clearance on January 4, 2001, as shown in the decision_date field, following its submission on August 15, 2000, and was granted a traditional 510(k) clearance.