Cleared Traditional

K960889 - SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS

K960889 is an FDA 510(k) clearance for SAPPHIRE PLUS SCALER MOD. 300114/PLUGGE..., manufactured by San Diego Swiss Machining, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K960889 · San Diego Swiss Machining, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
67d
Days
Class 2
Risk

K960889 is an FDA 510(k) clearance for the SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPRE.... Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by San Diego Swiss Machining, Inc. (San Diego, US). The FDA issued a Cleared decision on May 10, 1996 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 San Diego Swiss Machining, Inc. devices

FDA 510(k) Submission Details - K960889

510(k) Number K960889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1996
Decision Date May 10, 1996
Days to Decision 67 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: 128d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
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 - ELC Scaler, Ultrasonic

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