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FDA 510(k)

SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3

K-Number: K953235 · 1995-09-13

ApplicantThe Implant Center of the Palm Beaches
Decision Date1995-09-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3 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 1995-09-13 under 510(k) number K953235. 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 SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3?

SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3 is a medical device that received FDA 510(k) clearance on 1995-09-13. The listed applicant is The Implant Center of the Palm Beaches. The 510(k) number is K953235.

When did SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3 receive FDA 510(k) clearance?

SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3 received FDA 510(k) clearance on 1995-09-13, under 510(k) number K953235.

Who is the listed applicant for SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3?

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 SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3?

The FDA product code for SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3 is DZE.

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

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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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