Cleared Traditional

K032605 - METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING

K032605 is an FDA 510(k) clearance for METAPASTE CALCIUM HYDROXIDE WITH BARIUM..., manufactured by Meta Biomed Co., Ltd.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K032605 · Meta Biomed Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
44d
Days
Class 2
Risk

K032605 is an FDA 510(k) clearance for the METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Meta Biomed Co., Ltd. (Elmhurst, US). The FDA issued a Cleared decision on October 8, 2003 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 - K032605

510(k) Number K032605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2003
Decision Date October 08, 2003
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 128d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KIF Device Classification - Class 2, Special Controls

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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

Entela, Inc.

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 - KIF Resin, Root Canal Filling

All 138
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K032605.
ADSEAL ROOT CANAL SEALER
K042769 · Meta Biomed Co., Ltd. · Nov 2004
ENDOREZ
K042756 · Ultradent Products, Inc. · Oct 2004
DIAPEX
K033585 · Bisco, Inc. · Jan 2004
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
K032603 · Meta Biomed Co., Ltd. · Oct 2003
PULPDENT CALCIUM HYDROXIDE PREPARATION
K022734 · Pulpdent Corporation · Oct 2002
FIRST FILL R.C.S.
K011748 · Jeneric/Pentron, Inc. · Aug 2001