Cleared Traditional

K770129 - SPRINT S-2 INSTRU. CENTER (MODEL 92329)

K770129 is an FDA 510(k) clearance for SPRINT S-2 INSTRU. CENTER (MODEL 92329), manufactured by Chemetron Health Systems. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K770129 · Chemetron Health Systems · Dental device
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Jan 1977
Decision
7d
Days
Class 1
Risk

K770129 is an FDA 510(k) clearance for the SPRINT S-2 INSTRU. CENTER (MODEL 92329). Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Chemetron Health Systems (Mchenry, US). The FDA issued a Cleared decision on January 28, 1977 after a review of 7 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 Chemetron Health Systems devices

FDA 510(k) Submission Details - K770129

510(k) Number K770129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1977
Decision Date January 28, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 128d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

EBW Device Classification - Class 1, General Controls

Product Code EBW Controller, Foot, Handpiece And Cord
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.

Regulatory Peers - EBW Controller, Foot, Handpiece And Cord

All 60
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K770129.
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN
K964863 · Bell Intl., Inc. · Feb 1997
MODIFIED SITE PERISTALTIC FOOTSWITCH
K905620 · Site Microsurgical Systems, Inc. · Feb 1991
OPTIONAL ACCESSORY FOOT SWITCH MODEL 100
K790322 · Applied Medical Research · May 1979