Den-Mat Dentin Link

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862449 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Gingitract

  Class I

  FDA 510(k) K771973 Active Cleared 7 Nov 1977

• Kwikap

  Class I

  FDA 510(k) K772315 Active Cleared 3 Jan 1978

• Den-Mat Polishing Paste

  Class I

  FDA 510(k) K801225 Active Cleared 17 Jun 1980

• Den-Mat 4-Minute Denture Cleaner

  Class I

  FDA 510(k) K791925 Active Cleared 26 Oct 1979

• Den-Mat Cerinate Porcelain

  Class II

  FDA 510(k) K895731 Active Cleared 3 Aug 1990

• Den-Mat Gold Link (Formerly Den-Mat Metal Opaquer)

  Class II

  FDA 510(k) K860971 Active Cleared 25 Mar 1986

See all devices from Den-Mat Corp. →

• What is the Den-Mat Dentin Link used for in dental procedures?

  The Den-Mat Dentin Link is specifically designed to bond resin-based restorative materials to dentin, ensuring strong and durable adhesion. This is critical for the long-term stability of composite fillings and other tooth restorations, helping prevent gaps or failures at the bonding interface.

• Is the Den-Mat Dentin Link available as a single-use or reusable system?

  The Den-Mat Dentin Link can be supplied as either a single-use or reusable system, depending on the manufacturer’s specifications. This flexibility allows dental clinics to choose based on their workflow, infection control protocols, and cost considerations.

• How is the Den-Mat Dentin Link regulated by the FDA?

  The Den-Mat Dentin Link received FDA clearance under the 510(k) pathway (K862449) in 1986, classified as Substantially Equivalent (SESE) to a predicate device. It falls under Product Code EBF (Material, Tooth Shade, Resin) and is categorized as a Class II dental device, meaning it is subject to special controls but does not require pre-market approval.

• What storage and handling guidelines should be followed for the Den-Mat Dentin Link?

  While the data does not specify unique sterility or storage requirements beyond standard dental adhesive protocols, it is essential to follow general dental best practices for adhesive systems, such as protecting from contamination, extreme temperatures, and improper lighting. Always refer to the manufacturer’s instructions for precise handling.