Cleared Traditional

E-Temp (K211101) - FDA 510(k) Clearance

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

K211101 · Envisiontec GmbH · Dental device
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Jun 2021
Decision
62d
Days
Class 2
Risk

K211101 is an FDA 510(k) clearance for the E-Temp. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Envisiontec GmbH (Gladbeck, DE). The FDA issued a Cleared decision on June 14, 2021 after a review of 62 days - a notably fast clearance cycle.

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: 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 Envisiontec GmbH devices

Submission Details

510(k) Number K211101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2021
Decision Date June 14, 2021
Days to Decision 62 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
65d faster than avg
Panel avg: 127d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Qserve Group, Us, Inc.
Patsy J. Trisler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBG Crown And Bridge, Temporary, Resin

All 62
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K211101.
Hexa-Temp
K214071 · Spident Co., Ltd. · Mar 2022
UltraPrint-Dental Temp C&B UV
K213643 · Guangzhou Heygears IMC., Inc. · Jan 2022
C&B 5.0 Hybrid
K210817 · Arum Dentistry Co., Ltd. · Dec 2021
PuRE PMMA Disc
K201563 · Quest Dental USA Corp. · Apr 2021
Aidite PMMA
K190217 · Aidite (Qinhuangdao) Technology Co., Ltd. · Dec 2020
GR-17 Resin System
K201827 · Pro3dure Medical GmbH · Nov 2020