Cleared Traditional

K801228 - BONDALCAP (SILICO-PHOSPHATE)

K801228 is an FDA 510(k) clearance for BONDALCAP (SILICO-PHOSPHATE), manufactured by Vivadent (Usa), Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K801228 · Vivadent (Usa), Inc. · Dental device
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Jun 1980
Decision
12d
Days
Class 2
Risk

K801228 is an FDA 510(k) clearance for the BONDALCAP (SILICO-PHOSPHATE). Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Vivadent (Usa), Inc. (Mchenry, US). The FDA issued a Cleared decision on June 4, 1980 after a review of 12 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 Vivadent (Usa), Inc. devices

FDA 510(k) Submission Details - K801228

510(k) Number K801228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1980
Decision Date June 04, 1980
Days to Decision 12 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: 127d · This submission: 12d
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 433
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K801228.
HY-BOND POLYCARBOXYLATE CEMENT
K810764 · Shofu Dental Corp. · Jun 1981
HY-BOND ZINC PHOSPHATE CEMENT
K810765 · Shofu Dental Corp. · Jun 1981
SILICAP
K801227 · Vivadent (Usa), Inc. · Aug 1980
BONDALCAP (CARBOXYLATE)
K801229 · Vivadent (Usa), Inc. · Jun 1980
PROVIT
K800060 · Parker Laboratories, Inc. · Jan 1980
DENTAL CEMENT, ZINC PHOSPHATE
K790593 · Wallace A. Erickson & Co. · Jun 1979