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FDA 510(k)

AB DENTAL DEVICES IMPLANTS AND ACCESSORIES

K-Number: K112440 · 2012-04-18

ApplicantA.B. Dental Devices , Ltd.
Decision Date2012-04-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AB DENTAL DEVICES IMPLANTS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is A.B. Dental Devices , Ltd.. It received FDA 510(k) clearance on 2012-04-18 under 510(k) number K112440. 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 AB DENTAL DEVICES IMPLANTS AND ACCESSORIES?

AB DENTAL DEVICES IMPLANTS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2012-04-18. The listed applicant is A.B. Dental Devices , Ltd.. The 510(k) number is K112440.

When did AB DENTAL DEVICES IMPLANTS AND ACCESSORIES receive FDA 510(k) clearance?

AB DENTAL DEVICES IMPLANTS AND ACCESSORIES received FDA 510(k) clearance on 2012-04-18, under 510(k) number K112440.

Who is the listed applicant for AB DENTAL DEVICES IMPLANTS AND ACCESSORIES?

The FDA 510(k) record lists A.B. Dental Devices , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AB DENTAL DEVICES IMPLANTS AND ACCESSORIES?

The FDA product code for AB DENTAL DEVICES IMPLANTS AND ACCESSORIES is DZE.

Related Clinical Trials

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Other records listing A.B. Dental Devices , Ltd. 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.

K250806Dental Implant SystemK051719A.B. DENTAL DEVICES

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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