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FDA 510(k)

SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS

K-Number: K103089 · 2011-09-15

ApplicantMis - Implant Technologies , Ltd.
Decision Date2011-09-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Mis - Implant Technologies , Ltd.. It received FDA 510(k) clearance on 2011-09-15 under 510(k) number K103089. 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 SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS?

SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS is a medical device that received FDA 510(k) clearance on 2011-09-15. The listed applicant is Mis - Implant Technologies , Ltd.. The 510(k) number is K103089.

When did SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS receive FDA 510(k) clearance?

SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS received FDA 510(k) clearance on 2011-09-15, under 510(k) number K103089.

Who is the listed applicant for SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS?

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

What is the FDA product code for SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS?

The FDA product code for SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS is DZE.

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Other records listing Mis - Implant Technologies , 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.

K080458MIS CREST WIDENERK040807MIS DENTAL IMPLANT SYSTEM

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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