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FDA 510(k)

LEW MDI O-BALL COLLARED IMPLANT,

K-Number: K121707 · 2012-09-24

ApplicantPark Dental Research Corp.
Decision Date2012-09-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEW MDI O-BALL COLLARED IMPLANT, is the device name listed in this FDA 510(k) record. The listed applicant is Park Dental Research Corp.. It received FDA 510(k) clearance on 2012-09-24 under 510(k) number K121707. 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 LEW MDI O-BALL COLLARED IMPLANT,?

LEW MDI O-BALL COLLARED IMPLANT, is a medical device that received FDA 510(k) clearance on 2012-09-24. The listed applicant is Park Dental Research Corp.. The 510(k) number is K121707.

When did LEW MDI O-BALL COLLARED IMPLANT, receive FDA 510(k) clearance?

LEW MDI O-BALL COLLARED IMPLANT, received FDA 510(k) clearance on 2012-09-24, under 510(k) number K121707.

Who is the listed applicant for LEW MDI O-BALL COLLARED IMPLANT,?

The FDA 510(k) record lists Park Dental Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEW MDI O-BALL COLLARED IMPLANT,?

The FDA product code for LEW MDI O-BALL COLLARED IMPLANT, is DZE.

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Other records listing Park Dental Research Corp. 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.

K252976Park Dental Nylon MADK082800STAR/VENT INTERNAL HEX SCREW IMPLANTK854749STARTANIUS 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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