Force II
510(k) K895163
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895163 | Date27 Oct 1989 | 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- Withdrawn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
- DYH
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3750
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
Force II is a resin‑based adhesive, bracket and tooth conditioner intended for use in dental orthodontic applications. It is formulated to bond orthodontic brackets to tooth surfaces and condition the enamel for optimal attachment.
Force II has received FDA 510(k) clearance (K895163) as a Class II medical device and is listed under product code DYH. It is manufactured by American Orthodontics in Sheboygan, WI, and is supplied as a single‑use product in accordance with the clearance specifications.
From the manufacturer
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