Cleared Traditional

K081699 - PLANMECA SOVEREIGN (FDA 510(k) Clearance)

Class I Dental device.

K081699 · Planmeca USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
73d
Days
Class 1
Risk

K081699 is an FDA 510(k) clearance for the PLANMECA SOVEREIGN. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Planmeca USA, Inc. (Roselle, US). The FDA issued a Cleared decision on August 29, 2008 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Planmeca USA, Inc. devices

Submission Details

510(k) Number K081699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date August 29, 2008
Days to Decision 73 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
54d faster than avg
Panel avg: 127d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 283
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K081699.
Midmark Dental Delivery System
K251626 · Midmark Corporation · Nov 2025
K5 Cart, K5 Mount, K5 Swing
K251491 · Osstem Implant Company., Ltd. Chair Business · Jul 2025
Integral Dental Unit
K243130 · Guangdong Yadeng Medical Apparatus Co., Ltd., · Jun 2025
Integral Dental Units
K242611 · Mipont Medical Equipment Co., Ltd. · May 2025
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
K250473 · Dci International, LLC · Feb 2025
BDC Dental Unit
K242404 · Bdc Dental Corporation , Ltd. · Feb 2025