Cleared Traditional

K770215 - ACTIVATOR LIGHT

K770215 is an FDA 510(k) clearance for ACTIVATOR LIGHT, manufactured by Gte Sylvania, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K770215 · Gte Sylvania, Inc. · Dental device
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Apr 1977
Decision
72d
Days
Class 2
Risk

K770215 is an FDA 510(k) clearance for the ACTIVATOR LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Gte Sylvania, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 15, 1977 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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 Gte Sylvania, Inc. devices

FDA 510(k) Submission Details - K770215

510(k) Number K770215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1977
Decision Date April 15, 1977
Days to Decision 72 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 128d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 170
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K770215.
CAULK PRISMA-LITE
K801588 · Dentsply Intl. · Sep 1980
FOTOFILL ACTIVATOR LIGHT
K772278 · Johnson & Johnson Professionals, Inc. · Jan 1978
ULTRAVIOLET RAD-EMITTING LAMP
K771077 · Lee Pharmaceuticals · Jun 1977
NUVA-LITE II PHOTO-CURE UNIT
K770599 · Dentsply Intl. · Apr 1977
ESTILUX UV SYSTEM
K770113 · Degussa Dental, Inc. · Jan 1977