Cleared Traditional

K952693 - RAMITEC PENTA

K952693 is an FDA 510(k) clearance for RAMITEC PENTA, manufactured by Espe GmbH & Co. Kg.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K952693 · Espe GmbH & Co. Kg. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
66d
Days
Class 2
Risk

K952693 is an FDA 510(k) clearance for the RAMITEC PENTA. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Espe GmbH & Co. Kg. (Seefeld, DE). The FDA issued a Cleared decision on August 18, 1995 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Espe GmbH & Co. Kg. devices

FDA 510(k) Submission Details - K952693

510(k) Number K952693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1995
Decision Date August 18, 1995
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 254
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K952693.
RETRAC
K952728 · Centrix, Inc. · Sep 1995
AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING
K954223 · American Dental Products, Inc. · Sep 1995
DENTRAY II PLUS TRAY ADHESIVE
K952930 · Confi-Dental Products Co. · Sep 1995
PERMADYNE GARANT 2:1
K953374 · Espe GmbH & Co. Kg. · Aug 1995
PERMADYNE PENTA (HIGH & LOW VISCOSITY)
K953027 · Espe GmbH & Co. Kg. · Jul 1995
S & C VINYL POLYSILOXANE IMPRESSION MATERIAL
K951075 · S & C Polymer GmbH · Mar 1995