Cleared Traditional

K770067 - CYANOBOND

K770067 is an FDA 510(k) clearance for CYANOBOND, manufactured by Parker Laboratories, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K770067 · Parker Laboratories, Inc. · Dental device
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Jan 1977
Decision
13d
Days
Class 2
Risk

K770067 is an FDA 510(k) clearance for the CYANOBOND. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 25, 1977 after a review of 13 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.

FDA 510(k) Submission Details - K770067

510(k) Number K770067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1977
Decision Date January 25, 1977
Days to Decision 13 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
115d faster than avg
Panel avg: 128d · This submission: 13d
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 508
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K770067.
TONGUE BLADE HOLDER
K771481 · Welch Allyn, Inc. · Aug 1977
SCUTABOND
K771451 · Premier Dental Products Co. · Aug 1977
ESPETEMP (TEMP. CEMENT)
K770923 · Espe GmbH (Us) · Jun 1977
CIMPAT (PINK AND WHITE)
K761354 · Septodont, Inc. · Jan 1977
SELFAST
K761355 · Septodont, Inc. · Jan 1977
ZINC CEMENT
K760978 · Adp Intl., Inc. · Nov 1976
K770067 · CYANOBOND
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