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FDA 510(k)

SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS

K-Number: K102308 · 2010-11-22

ApplicantDentium Co., Ltd.
Decision Date2010-11-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd.. It received FDA 510(k) clearance on 2010-11-22 under 510(k) number K102308. 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 SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS?

SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS is a medical device that received FDA 510(k) clearance on 2010-11-22. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K102308.

When did SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS receive FDA 510(k) clearance?

SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS received FDA 510(k) clearance on 2010-11-22, under 510(k) number K102308.

Who is the listed applicant for SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS?

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

What is the FDA product code for SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS?

The FDA product code for SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS is DZE.

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Other records listing Dentium Co., Ltd. as applicant

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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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