Medizin Produkte Neustadt GmbH (Mpn) · Class U · Cleared Dec 18, 2025
| K-number | K253758 |
| Device name | Dental Cone; Dental Sponge |
| Applicant | Medizin Produkte Neustadt GmbH (Mpn) |
| Product code | OLR |
| Device class | Class U |
| Decision date | Dec 18, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
The Dental Cone and Dental Sponge are sterile, non-pyrogenic collagen matrix dressings made from purified type I collagen derived from bovine Achilles tendon. They are indicated for the management of oral wounds and sores, including denture sores, oral ulcers, periodontal surgical wounds, suture sites, burns, surgical wounds, and traumatic wounds.
The subject device and predicate device have identical design, material, chemical composition, and principles of operation. The subject device introduces an additional sterilization method using ethylene oxide and an alternative packaging configuration; these changes do not affect safety or effectiveness.
Not stated in this summary.
The subject and predicate devices are substantially equivalent because they have identical indications for use, identical design, material, chemical composition, and principles of operation. Minor differences in sterilization method (ethylene oxide) and packaging configuration do not impact the safety or effectiveness of the device.
View the full FDA submission: accessdata.fda.gov