Cleared Traditional

ULTRAPAK NEHA (K010070) - FDA 510(k) Clearance

K010070 · Ultradent Products, Inc. · Dental device
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Mar 2001
Decision
66d
Days
-
Risk

K010070 is an FDA 510(k) clearance for the ULTRAPAK NEHA. Classified as Cord, Retraction (product code MVL).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on March 15, 2001 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. 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 Ultradent Products, Inc. devices

Submission Details

510(k) Number K010070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2001
Decision Date March 15, 2001
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 127d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 35
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K010070.
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VOCO Retraction Paste
K213149 · Voco GmbH · Dec 2021