Cleared Traditional

K101880 - TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT

K101880 is an FDA 510(k) clearance for TAPERED SCREW-VENT T IMPLANT, manufactured by Zimmer Dental, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K101880 · Zimmer Dental, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
87d
Days
Class 2
Risk

K101880 is an FDA 510(k) clearance for the TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Zimmer Dental, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 1, 2010 after a review of 87 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.

FDA 510(k) Submission Details - K101880

510(k) Number K101880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2010
Decision Date October 01, 2010
Days to Decision 87 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
41d faster than avg
Panel avg: 128d · This submission: 87d
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 1546
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K101880.
ENDOSSEOUS DENTAL IMPLANT
K093562 · Southern Implants, Inc. · Oct 2010
HT III SA FIXTURE SYSTEM
K101096 · Hiossen, Inc. · Oct 2010
BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT
K101849 · Bicon, LLC · Oct 2010
TAPERED SCREW-VENT T IMPLANT
K101977 · Zimmer Dental, Inc. · Sep 2010
STAR/VENT INTERNAL HEX SCREW IMPLANT
K082800 · Park Dental Research Corp. · Aug 2010
NEODENT IMPLANT SYSTEM
K101207 · Jjgc Industria E Comercio DE Materiais Dentarios S · Aug 2010
K101880 · TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT
Download PDF FDA Summary Zimmer Dental, Inc.