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FDA 510(k)

STAR/VENT INTERNAL HEX SCREW IMPLANT

K-Number: K082800 · 2010-08-26

ApplicantPark Dental Research Corp.
Decision Date2010-08-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STAR/VENT INTERNAL HEX SCREW 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 2010-08-26 under 510(k) number K082800. 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 STAR/VENT INTERNAL HEX SCREW IMPLANT?

STAR/VENT INTERNAL HEX SCREW IMPLANT is a medical device that received FDA 510(k) clearance on 2010-08-26. The listed applicant is Park Dental Research Corp.. The 510(k) number is K082800.

When did STAR/VENT INTERNAL HEX SCREW IMPLANT receive FDA 510(k) clearance?

STAR/VENT INTERNAL HEX SCREW IMPLANT received FDA 510(k) clearance on 2010-08-26, under 510(k) number K082800.

Who is the listed applicant for STAR/VENT INTERNAL HEX SCREW 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 STAR/VENT INTERNAL HEX SCREW IMPLANT?

The FDA product code for STAR/VENT INTERNAL HEX SCREW 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 MADK121707LEW MDI O-BALL COLLARED IMPLANT,K854749STARTANIUS 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

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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