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FDA 510(k)

BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM)

K-Number: K951937 · 1995-06-05

ApplicantBio Path
Decision Date1995-06-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM) is the device name listed in this FDA 510(k) record. The listed applicant is Bio Path. It received FDA 510(k) clearance on 1995-06-05 under 510(k) number K951937. 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 BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM)?

BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM) is a medical device that received FDA 510(k) clearance on 1995-06-05. The listed applicant is Bio Path. The 510(k) number is K951937.

When did BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM) receive FDA 510(k) clearance?

BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM) received FDA 510(k) clearance on 1995-06-05, under 510(k) number K951937.

Who is the listed applicant for BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM)?

The FDA 510(k) record lists Bio Path as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM)?

The FDA product code for BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM) is DZE.

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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

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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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