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FDA 510(k)

DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S

K-Number: K120530 · 2012-07-05

ApplicantDentin Implants Technologies , Ltd.
Decision Date2012-07-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S is the device name listed in this FDA 510(k) record. The listed applicant is Dentin Implants Technologies , Ltd.. It received FDA 510(k) clearance on 2012-07-05 under 510(k) number K120530. 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 DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S?

DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S is a medical device that received FDA 510(k) clearance on 2012-07-05. The listed applicant is Dentin Implants Technologies , Ltd.. The 510(k) number is K120530.

When did DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S receive FDA 510(k) clearance?

DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S received FDA 510(k) clearance on 2012-07-05, under 510(k) number K120530.

Who is the listed applicant for DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S?

The FDA 510(k) record lists Dentin Implants Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S?

The FDA product code for DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S is DZE.

Related Clinical Trials

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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

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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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