Cleared Traditional

K841826 - NATURA-DENT VACUUM-FIRED PORCELAIN TEETH

K841826 is an FDA 510(k) clearance for NATURA-DENT VACUUM-FIRED PORCELAIN TEETH, manufactured by Parexel Intl. Corp.. The device is a Class 2 Dental device with product code ELL cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K841826 · Parexel Intl. Corp. · Dental device
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Jul 1984
Decision
71d
Days
Class 2
Risk

K841826 is an FDA 510(k) clearance for the NATURA-DENT VACUUM-FIRED PORCELAIN TEETH. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Parexel Intl. Corp. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1984 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - 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 Parexel Intl. Corp. devices

FDA 510(k) Submission Details - K841826

510(k) Number K841826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1984
Decision Date July 12, 1984
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 128d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELL Device Classification - Class 2, Special Controls

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
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 - ELL Teeth, Porcelain

All 31
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K841826.
DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM
K871808 · Degussa Dental, Inc. · Jun 1987
MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN
K864724 · Dentsply Intl. · Feb 1987
ARTIFICIAL TEETH, PORCELAIN, MODIFIED
K860608 · Dentsply Intl. · Mar 1986
PORCELAIN ARTIFICIAL TEETH
K823744 · Dentsply Intl. · Dec 1982
NU-GLAZE
K781935 · Deringer-Ney, Inc. · Dec 1978
BIOBOND MASTER STAIN AND GLAZE KIT
K771179 · Dentsply Intl. · Jul 1977