Cleared Traditional

K080882 - CEREC OPTI SPRAY (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080882 · Sirona Dental Systems GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
11d
Days
Class 2
Risk

K080882 is an FDA 510(k) clearance for the CEREC OPTI SPRAY. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on April 11, 2008 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Sirona Dental Systems GmbH devices

Submission Details

510(k) Number K080882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date April 11, 2008
Days to Decision 11 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 127d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 401
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K080882.
Dia-X Sil Bite
K254112 · DiaDent Group International · Mar 2026
Hydro Print Premium Fast Set - 454g (1lb) (052037)
K253501 · Vigodent Ind?stria E Comercio Ltda · Oct 2025
JET BITE
K250969 · Dent4you AG · Jun 2025
Elastic Impression Material
K241924 · Beijing Okvd Biological Technology , Ltd. · Dec 2024
Speedex Light Body
K242360 · Dent4you AG · Nov 2024
Chemi-SiL (HB, MB, LB, LBS)
K233954 · B&E Korea Co., Ltd. · Feb 2024