Cleared Traditional

K810765 - HY-BOND ZINC PHOSPHATE CEMENT

K810765 is an FDA 510(k) clearance for HY-BOND ZINC PHOSPHATE CEMENT, manufactured by Shofu Dental Corp.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K810765 · Shofu Dental Corp. · Dental device
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Jun 1981
Decision
81d
Days
Class 2
Risk

K810765 is an FDA 510(k) clearance for the HY-BOND ZINC PHOSPHATE CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Shofu Dental Corp. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 81 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 - K810765

510(k) Number K810765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1981
Decision Date June 12, 1981
Days to Decision 81 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
47d faster than avg
Panel avg: 128d · This submission: 81d
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 487
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K810765.
KETAC-CHEM
K812115 · Espe-Premier Sales Co. · Aug 1981
FUJI IONOMER TYPE I & II
K811521 · G-C Intl. Corp. · Jun 1981
HY-BOND POLYCARBOXYLATE CEMENT
K810764 · Shofu Dental Corp. · Jun 1981
PCA PERIOCARE PERIODONTAL DRESSING
K810545 · Pulpdent Corp. of America · Mar 1981
DENTAL ENDODONTIC CEMENT
K810026 · Witech Laboratory · Jan 1981
SILICAP
K801227 · Vivadent (Usa), Inc. · Aug 1980
K810765 · HY-BOND ZINC PHOSPHATE CEMENT
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