TP Screw Implant 3.75, 4.0-B5

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K952998 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Wide Screws Tp-4K, Pros-G4, Tools G4 or 17-4 Ss

  Class II

  FDA 510(k) K952988 Active Cleared 26 Jul 1995

• Tp-4K Screw Implant 3.3, 3.75, 4.0

  Class II

  FDA 510(k) K953001 Active Cleared 31 Oct 1995

• Ha, Tp Cylinder, Unihole

  Class II

  FDA 510(k) K953280 Active Cleared 15 Sep 1995

• Wide Str-Tp-4K, Pros Str, Cly-Str-Tp 4

  Class II

  FDA 510(k) K952989 Active Cleared 26 Jul 1995

• Kis-- Four Hole Cylinder

  Class II

  FDA 510(k) K953139 Active Cleared 13 Sep 1995

• Tp-4 Wide Cylinder Implants

  Class II

  FDA 510(k) K952994 Active Cleared 31 Oct 1995

See all devices from Implant Center of the Palm Beaches →

• What is the TP Screw Implant 3.75, 4.0-B5 used for?

  The TP Screw Implant 3.75, 4.0-B5 is a dental implant device designed for surgical insertion into bone tissue. It is intended for dental applications and is available in 3.75mm and 4.0mm sizes with the B5 reference code.

• Is the TP Screw Implant reusable or single-use?

  The TP Screw Implant is supplied as a sterile, single-use device. It is not intended to be reused after surgical insertion into bone tissue.

• What regulatory clearance has the TP Screw Implant received?

  The TP Screw Implant received FDA 510(k) clearance on October 31, 1995, with the K number K952998. It was determined to be substantially equivalent to predicate devices and is classified as a class II medical device under the DZE product code category.

• How should the TP Screw Implant be stored?

  The TP Screw Implant should be stored according to the manufacturer's instructions. It is not indicated for MRI environments, so storage should avoid conditions where MRI exposure might occur.