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FDA 510(k)

MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM

K-Number: K082843 · 2009-06-19

ApplicantDentis Co., Ltd.
Decision Date2009-06-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentis Co., Ltd.. It received FDA 510(k) clearance on 2009-06-19 under 510(k) number K082843. 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 MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM?

MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-06-19. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K082843.

When did MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2009-06-19, under 510(k) number K082843.

Who is the listed applicant for MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM?

The FDA product code for MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM is DZE.

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Other records listing Dentis Co., Ltd. as applicant

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K253493Dentis SQ-SL AXEL FixtureK241065ChecQ (AC100)K233921Luvis Chair (LC700C)K241063s-Clean ScanHealing AbutmentK240511Dentis s-Clean SQ-SL FixtureK233544MESHEET

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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

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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