Cleared Traditional

K061530 - MD-TEMP

K061530 is an FDA 510(k) clearance for MD-TEMP, manufactured by Meta Biomed Co., Ltd.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K061530 · Meta Biomed Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
49d
Days
Class 2
Risk

K061530 is an FDA 510(k) clearance for the MD-TEMP. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Meta Biomed Co., Ltd. (Cheongju City, Chungbuk, KR). The FDA issued a Cleared decision on July 21, 2006 after a review of 49 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 Meta Biomed Co., Ltd. devices

FDA 510(k) Submission Details - K061530

510(k) Number K061530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2006
Decision Date July 21, 2006
Days to Decision 49 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
79d faster than avg
Panel avg: 128d · This submission: 49d
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 K061530.
VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310
K070991 · Vita · Jun 2007
KAVO EVEREST C-TEMP
K063624 · Kavo America · Feb 2007
ARTEGRAL IMCROWN
K061809 · Merz Dental GmbH · Sep 2006
TEMPFX ESTHETIC PROVISIONAL SYSTEM
K061264 · Dentsply International, Inc. · May 2006
TEMPORARY CROWN & BRIDGE RESIN
K060881 · Cosmedent, Inc. · May 2006
PROVISIONAL INLAY/ONLAY KIT
K052800 · Dmg USA, Inc. · Mar 2006