Cleared Traditional

K011001 - TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA...

K011001 · Satelec · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
90d
Days
-
Risk

K011001 is an FDA 510(k) clearance for the TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM. Classified as Device, Electrical Dental Anesthesia (product code LWM).

Submitted by Satelec (Wellesley, US). The FDA issued a Cleared decision on June 7, 2001 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K011001

510(k) Number K011001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2001
Decision Date June 07, 2001
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LWM Device Classification - Class 0,

Product Code LWM Device, Electrical Dental Anesthesia
Device Class -

Regulatory Peers - LWM Device, Electrical Dental Anesthesia

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