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FDA 510(k)

LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)

K-Number: K050257 · 2005-02-07

ApplicantMondeal Medical Systems GmbH
Decision Date2005-02-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Mondeal Medical Systems GmbH. It received FDA 510(k) clearance on 2005-02-07 under 510(k) number K050257. 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 LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)?

LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE) is a medical device that received FDA 510(k) clearance on 2005-02-07. The listed applicant is Mondeal Medical Systems GmbH. The 510(k) number is K050257.

When did LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE) receive FDA 510(k) clearance?

LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE) received FDA 510(k) clearance on 2005-02-07, under 510(k) number K050257.

Who is the listed applicant for LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)?

The FDA 510(k) record lists Mondeal Medical Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)?

The FDA product code for LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE) is DZE.

Related Clinical Trials

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.

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Other records listing Mondeal Medical Systems GmbH 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.

K072740MONDEAL EXTREMITY BONE FIXATION SYSTEMK071797MONDEAL HAND CONTOUR SYSTEMK071798MONDEAL DISTAL RADIUS SYSTEMK062436SIS SINUS IMPLANT STABILIZERK042345LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)

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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