Cleared Traditional

K880562 - ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT

K880562 is an FDA 510(k) clearance for ADDITIONAL CLAIMS TO DENTAL RESTORATIVE..., manufactured by Macrochem Corp.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K880562 · Macrochem Corp. · Dental device
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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

FDA 510(k) Submission Details - K880562

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
62d slower than avg
Panel avg: 128d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYH Device Classification - Class 2, Special Controls

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 151
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K880562.
NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC
K890834 · Scientific Pharmaceuticals, Inc. · May 1989
FRS LITE FLUORIDE RELEASING SEALANT
K890740 · Ormco Corp. · Apr 1989
ORTHO-SEAL
K883465 · Bisco, Inc. · Oct 1988
MAXIMUM CURE SEALANT
K880791 · Reliance Orthodontic Products, Inc. · Jun 1988
LIGHT BOND
K880793 · Reliance Orthodontic Products, Inc. · Jun 1988
RELIANCE METAL PRIMER
K880766 · Reliance Orthodontic Products, Inc. · Apr 1988