Cleared Traditional

K160786 - RODO Abutment System

K160786 is the FDA 510(k) clearance for RODO Abutment System by Rodo Medical, Inc.. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K160786 · Rodo Medical, Inc. · Dental device
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Nov 2016
Decision
244d
Days
Class 2
Risk

K160786 is an FDA 510(k) clearance for the RODO Abutment System. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Rodo Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on November 21, 2016 after a review of 244 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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.

View all Rodo Medical, Inc. devices

Submission Details

510(k) Number K160786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2016
Decision Date November 21, 2016
Days to Decision 244 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 127d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 464
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K160786.
On1 Concept
K161655 · Nobel Biocare AB · Feb 2017
Transfer & Angled Abutment
K153015 · Osstem Implant Co., Ltd. · Dec 2016
Temporary Snap Abutment
K161435 · Nobel Biocare AB · Nov 2016
Inclusive Abutments
K160979 · Prismatik Dentalcraft, Inc. · Nov 2016
Link Abutment for CEREC
K160519 · Osstem Implant Co., Ltd. · Oct 2016
Straumann Sterile Healing Solution
K161677 · Institut Straumann AG · Oct 2016