(23 days)
Indicated for the management of oral wounds and sores, including: denture sores, oral ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, surgical wounds and traumatic wounds.
Dental Cone and Sponge are collagen matrices, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Dental Cone and Sponge are supplied sterile, non-pyrogenic, and for single use only.
N/A
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
December 18, 2025
Medizin Produkte Neustadt GmbH (Mpn)
Danielle Lindner
Regulatory Affairs Manager
Donaustrasse 24
Saal/Donau Bavaria, 93342
Germany
Re: K253758
Trade/Device Name: Dental Cone; Dental Sponge
Regulatory Class: Unclassified
Product Code: OLR
Dated: November 25, 2025
Received: November 25, 2025
Dear Danielle Lindner:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K253758 - Danielle Lindner Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K253758 - Danielle Lindner Page 3
Sincerely,
Bobak Shirmohammadi -S
For Michael E Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253758 |
|---|---|
| Please provide the device trade name(s). |
Dental Cone;
Dental Sponge
| Please provide your Indications for Use below. |
|---|
Indicated for the management of oral wounds and sores, including: denture sores, oral ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, surgical wounds and traumatic wounds.
| Please select the types of uses (select one or both, as applicable). | ☒ Prescription Use (21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
Page 5
510(k) Summary
510(k) #: K253758
Prepared on: 2025-11-25
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Medizin Produkte Neustadt GmbH (MPN) |
|---|---|
| Applicant Address | Donaustrasse 24 Saal/Donau Bavaria 93342 Germany |
| Applicant Contact Telephone | (503)858-3083 |
| Applicant Contact | Mrs. Danielle Lindner |
| Applicant Contact Email | danielle.lindner@admedsol.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | Dental Cone; Dental Sponge |
|---|---|
| Common Name | Oral wound dressing |
| Classification Name | Oral wound dressing |
| Regulation Number | Unclassified |
| Product Code(s) | OLR, KGN |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K133290 | Collacare Dental | KGN |
Device Description Summary
21 CFR 807.92(a)(4)
Dental Cone and Sponge are collagen matrices, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Dental Cone and Sponge are supplied sterile, non-pyrogenic, and for single use only.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Indicated for the management of oral wounds and sores, including: denture sores, oral ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, surgical wounds and traumatic wounds.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use of the subject and predicate devices are identical.
Technological Comparison
21 CFR 807.92(a)(6)
The subject device and the predicate device have identical design, material, chemical composition, and principles of operations. An additional sterilization method (ethylene oxide) and an alternative packaging configuration is presented. These changes do not affect the safety or effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
N/A