Fomed Industries, Inc. · Class II · Cleared Jun 10, 2025
| K-number | K250735 |
| Device name | Dental Barrier and Sleeves |
| Applicant | Fomed Industries, Inc. |
| Product code | PEM |
| Device class | Class II |
| Decision date | Jun 10, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4370 |
The Dental Barrier and Sleeves are disposable polyethylene covers designed to protect dental instruments and equipment during clinical use. They come in various sizes and shapes, fit over hand-held instruments such as handpieces, curing lights, and air/water syringes, and are intended for single-patient use only.
The subject device and predicate have identical intended use, material composition, sterility designation, biocompatibility, and performance properties. Both are single-use devices with very similar specifications and tolerances; minor differences in specifications do not raise safety or effectiveness questions.
Performance testing was conducted per ASTM F1670 (resistance to penetration), ASTM F1671 (tear resistance), ASTM D882 (tensile strength), ASTM F1342 (puncture resistance), and ASTM D1004 (additional testing).
The subject device meets the same intended use, principles of operation, material composition, sterility, biocompatibility, and performance characteristics as the predicate device (BH Medical Dental Barrier Sleeves and Barrier Film). Both undergo identical performance testing with results meeting all key characteristics. The minor specification and tolerance differences do not raise questions about safety and effectiveness, making the devices essentially equivalent.
View the full FDA submission: accessdata.fda.gov