Cleared Traditional

K952988 - WIDE SCREWS TP-4K, PROS-G4, TOOLS G4 OR 17-4 SS

K952988 is an FDA 510(k) clearance for WIDE SCREWS TP-4K, manufactured by Implant Center of the Palm Beaches. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K952988 · Implant Center of the Palm Beaches · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
33d
Days
Class 2
Risk

K952988 is an FDA 510(k) clearance for the WIDE SCREWS TP-4K, PROS-G4, TOOLS G4 OR 17-4 SS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Center of the Palm Beaches (N. Palm Beach, US). The FDA issued a Cleared decision on July 26, 1995 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Implant Center of the Palm Beaches devices

FDA 510(k) Submission Details - K952988

510(k) Number K952988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1995
Decision Date July 26, 1995
Days to Decision 33 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 127d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 868
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K952988.
HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K950624 · Lifecore Biomedical, Inc. · Aug 1995
LAPPING TOOL KIT
K953103 · Steri-Oss, Inc. · Aug 1995
BRANEMARK SYSTEM BALL ATTACHMENT SYSTEM
K952676 · Nobelpharma USA, Inc. · Aug 1995
WIDE STR-TP-4K, PROS STR, CLY-STR-TP 4
K952989 · Implant Center of the Palm Beaches · Jul 1995
KIS-II IMPLANT FIXTURES
K951606 · Implant Center of the Palm Beaches · Jul 1995
BIO-VENT IMPLANT
K950575 · Core-Vent Corp. · Jul 1995