Cleared Traditional

Hexa-Temp (K214071) - FDA 510(k) Clearance

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

K214071 · Spident Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
73d
Days
Class 2
Risk

K214071 is an FDA 510(k) clearance for the Hexa-Temp. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Spident Co., Ltd. (Gojan-Dong, Namdong-Gu, KR). The FDA issued a Cleared decision on March 10, 2022 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Spident Co., Ltd. devices

Submission Details

510(k) Number K214071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date March 10, 2022
Days to Decision 73 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
54d faster than avg
Panel avg: 127d · This submission: 73d
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 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 K214071.
PMMA BLOCK
K223706 · Huliang(Shanghai) Bio-Tech Co., Ltd. · May 2023
PMMA Blocks for Dental Use
K223477 · Aidite (Qinhuangdao) Technology Co., Ltd. · Feb 2023
CURA-Temp
K202965 · Mgnewton , Ltd. · Dec 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
E-Temp
K211101 · Envisiontec GmbH · Jun 2021