Cleared Traditional

K801688 - TORX HANDPIECE CONTRA ANGLES ATTACHMENTS

K801688 is an FDA 510(k) clearance for TORX HANDPIECE CONTRA ANGLES ATTACHMENTS, manufactured by Pacific Dental Corp.. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K801688 · Pacific Dental Corp. · Dental device
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Aug 1980
Decision
14d
Days
Class 1
Risk

K801688 is an FDA 510(k) clearance for the TORX HANDPIECE CONTRA ANGLES ATTACHMENTS. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Pacific Dental Corp. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1980 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Pacific Dental Corp. devices

FDA 510(k) Submission Details - K801688

510(k) Number K801688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1980
Decision Date August 04, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 127d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.