Cleared Traditional

ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT (K880562) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880562 · Macrochem Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
190d
Days
Class 2
Risk

K880562 is an FDA 510(k) clearance for the ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Macrochem Corp. (Woburn, US). The FDA issued a Cleared decision on August 19, 1988 after a review of 190 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Macrochem Corp. devices

Submission Details

510(k) Number K880562 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 11, 1988
Decision Date August 19, 1988
Days to Decision 190 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 127d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 23
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K880562.
LC BRACKET ADHESIVE SYSTEM
K050750 · Dentsply Intl. · Apr 2005
IDEAL 1 ORTHODONTIC BAND CEMENT
K040375 · Dentsply Intl. · Apr 2004
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
K033703 · Dentsply Intl. · Feb 2004
ACCLAIM* BRACKET ADHESIVE
K864008 · Johnson & Johnson Professionals, Inc. · Oct 1986
EXCEL BRACKET ADHESIVE
K854050 · Johnson & Johnson Professionals, Inc. · Nov 1985
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE
K853523 · Dentsply Intl. · Nov 1985