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FDA 510(k)

BIO-VENT X IMPLANT

K-Number: K950576 · 1995-07-11

ApplicantCore-Vent Corp.
Decision Date1995-07-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-VENT X IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Core-Vent Corp.. It received FDA 510(k) clearance on 1995-07-11 under 510(k) number K950576. 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 BIO-VENT X IMPLANT?

BIO-VENT X IMPLANT is a medical device that received FDA 510(k) clearance on 1995-07-11. The listed applicant is Core-Vent Corp.. The 510(k) number is K950576.

When did BIO-VENT X IMPLANT receive FDA 510(k) clearance?

BIO-VENT X IMPLANT received FDA 510(k) clearance on 1995-07-11, under 510(k) number K950576.

Who is the listed applicant for BIO-VENT X IMPLANT?

The FDA 510(k) record lists Core-Vent Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-VENT X IMPLANT?

The FDA product code for BIO-VENT X IMPLANT is DZE.

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Other records listing Core-Vent 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.

K002614ADVENT IMPLANT SYSTEMK002188SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D,K950579MICRO-VENT IMPLANTK950575BIO-VENT IMPLANTK950578SCREW-VENT IMPLANTK950577SWEDE-VENT IMPLANT

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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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