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FDA 510(k)

PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG'

K-Number: K953237 · 1995-09-15

ApplicantThe Implant Center of the Palm Beaches
Decision Date1995-09-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG' is the device name listed in this FDA 510(k) record. The listed applicant is The Implant Center of the Palm Beaches. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K953237. 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 PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG'?

PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG' is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is The Implant Center of the Palm Beaches. The 510(k) number is K953237.

When did PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG' receive FDA 510(k) clearance?

PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG' received FDA 510(k) clearance on 1995-09-15, under 510(k) number K953237.

Who is the listed applicant for PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG'?

The FDA 510(k) record lists The Implant Center of the Palm Beaches as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG'?

The FDA product code for PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG' is DZE.

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Other records listing The Implant Center of the Palm Beaches as applicant

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Official Source

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