Cleared Traditional

GIRAFFE2 (K102133) - FDA 510(k) Clearance

K102133 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
70d
Days
-
Risk

K102133 is an FDA 510(k) clearance for the GIRAFFE2. Classified as Cord, Retraction (product code MVL).

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on October 7, 2010 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. 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 Kerr Corporation devices

Submission Details

510(k) Number K102133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2010
Decision Date October 07, 2010
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 35
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K102133.
CyClean Cord
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Stasis Gel
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Gingi-Aid Gel
K211419 · Belport Company, Inc., Gingi-Pak · Jan 2022
VOCO Retraction Paste
K213149 · Voco GmbH · Dec 2021