Microdapt Dental Restorative Bonding
by Johnson & Johnson Professionals, Inc.
510(k) K830387
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830387 | Date17 Mar 1983 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KLE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3200
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Microdapt Dental Restorative Bonding is an agent used for tooth bonding with resin, classified under product code KLE and device class 2. It is a dental device intended for use in restorative procedures involving bonding agents.
The device was cleared via the FDA 510(k) process under K830387 on March 17, 1983, with a substantially equivalent decision. It is supplied as a non-sterile, single-use or reusable agent depending on clinical protocol, and is regulated under 21 CFR 872.3200 for dental specialty use.
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Questions
AI-generated answers, 25 Sep 2026
What is the Microdapt Dental Restorative Bonding used for?
It is used as an agent for tooth bonding with resin in restorative dental procedures, as specified in its intended use for bonding agents in dental restorations.
How is the Microdapt Dental Restorative Bonding supplied and is it sterile?
It is supplied as a non-sterile agent, meaning it does not undergo sterilization processes prior to distribution, and its use depends on clinical protocol for single-use or reusable application.
What regulatory pathway was used to clear the Microdapt Dental Restorative Bonding?
It was cleared via the FDA 510(k) process under submission K830387, receiving a substantially equivalent decision on March 17, 1983, based on comparison to a legally marketed predicate device.