Cleared Traditional

K102776 - EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM

K102776 is an FDA 510(k) clearance for EXTRA-ORAL, manufactured by Deltamed GmbH. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K102776 · Deltamed GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
147d
Days
Class 2
Risk

K102776 is an FDA 510(k) clearance for the EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Deltamed GmbH (Friedberg, DE). The FDA issued a Cleared decision on February 18, 2011 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Deltamed GmbH devices

FDA 510(k) Submission Details - K102776

510(k) Number K102776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2010
Decision Date February 18, 2011
Days to Decision 147 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
19d slower than avg
Panel avg: 128d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 170
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K102776.
TEMPFLEX
K110747 · Kerr Corporation · Jun 2011
PRO-V COAT
K103514 · Bisco, Inc. · May 2011
SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
K110484 · Novocol, Inc. · May 2011
TELIO CS INLAY & TELIO CS ONLAY
K103379 · Ivoclar Vivadent, Inc. · Feb 2011
ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
K103474 · Micerium S.P.A. · Feb 2011
TURBO TEMP 3
K102753 · Danville Materials, Inc. · Feb 2011