Cleared Traditional

K880848 - FUJI CAP II CAPSULE & APPLIER

K880848 is an FDA 510(k) clearance for FUJI CAP II CAPSULE & APPLIER, manufactured by G-C Intl. Corp.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K880848 · G-C Intl. Corp. · Dental device
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May 1988
Decision
76d
Days
Class 2
Risk

K880848 is an FDA 510(k) clearance for the FUJI CAP II CAPSULE & APPLIER. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by G-C Intl. Corp. (Scottsdale, US). The FDA issued a Cleared decision on May 16, 1988 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 G-C Intl. Corp. devices

FDA 510(k) Submission Details - K880848

510(k) Number K880848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date May 16, 1988
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 338
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K880848.
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K872984 · Espe GmbH (Us) · Mar 1988