Cleared Traditional

K161281 - Dentalis Bio Solution Implants

K161281 is an FDA 510(k) clearance for Dentalis Bio Solution Implants, manufactured by Dentalis Bio Solution Implants, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K161281 · Dentalis Bio Solution Implants, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
250d
Days
Class 2
Risk

K161281 is an FDA 510(k) clearance for the Dentalis Bio Solution Implants. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentalis Bio Solution Implants, LLC (Indianapolis, US). The FDA issued a Cleared decision on January 11, 2017 after a review of 250 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K161281

510(k) Number K161281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2016
Decision Date January 11, 2017
Days to Decision 250 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 128d · This submission: 250d
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 1424
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K161281.
US SA Implant System
K161103 · Osstem Implant Co., Ltd. · Feb 2017
GMI Frontier Dental Implant System
K161593 · Ilerimplant S.L · Jan 2017
SuperLine
K160965 · Dentium Co., Ltd. · Jan 2017
Chaorum Implant System
K160536 · Medimecca Co., Ltd. · Jan 2017
Ritter Dental Implant System
K160475 · Ritter Implants GmbH CO KG · Dec 2016
s-Clean OneQ-SL Narrow Implant System
K161244 · Dentis Co., Ltd. · Dec 2016