Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CAM Titanium Blanks

K-Number: K160784 · 2016-09-14

ApplicantAltatec GmbH
Decision Date2016-09-14
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAM Titanium Blanks is the device name listed in this FDA 510(k) record. The listed applicant is Altatec GmbH. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K160784. 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 CAM Titanium Blanks?

CAM Titanium Blanks is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Altatec GmbH. The 510(k) number is K160784.

When did CAM Titanium Blanks receive FDA 510(k) clearance?

CAM Titanium Blanks received FDA 510(k) clearance on 2016-09-14, under 510(k) number K160784.

Who is the listed applicant for CAM Titanium Blanks?

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

What is the FDA product code for CAM Titanium Blanks?

The FDA product code for CAM Titanium Blanks is NHA.

Other records listing Altatec GmbH 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.

K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsK153779Abutment for BridgesK152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)

Related Devices (Code: NHA)

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.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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.

↑