UltraSeal XT Plus
510(k) K993846
Active
Valid until
No date given
FDA recalls
None ongoingTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK993846 | Date16 Feb 2000 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
-
- Terminated Z-0704-2017
There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- EBC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3765
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The UltraSeal XT Plus is a dental sealant, pit and fissure conditioner designed to protect tooth enamel from decay by sealing the deep grooves and fissures where bacteria and food particles can accumulate. Classified as a Class II medical device, it adheres to the occlusal surfaces of molars and premolars to create a physical barrier against caries development.
Supplied as a single-use product, the UltraSeal XT Plus is intended for use in dental offices and requires no special storage conditions beyond protection from extreme temperatures. It is regulated under FDA 510(k) clearance (K993846) and the EU Medical Device Regulation (MDR), with a regulatory classification of 872.3765. The device is non-sterile and must be prepared and applied by a dental professional following manufacturer instructions.
Other devices from Ultradent Products, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the UltraSeal XT Plus designed to protect against in dental patients?
The UltraSeal XT Plus is specifically designed to protect tooth enamel from decay by sealing deep grooves and fissures on the occlusal surfaces of molars and premolars. These areas are prone to bacterial accumulation and food particle entrapment, which can lead to caries (tooth decay). By creating a physical barrier, the sealant helps prevent the development of cavities in these high-risk regions.
Is the UltraSeal XT Plus intended for single-use only, and how should it be stored?
Yes, the UltraSeal XT Plus is supplied as a single-use product, meaning each application requires a new unit. Storage is straightforward—it only requires protection from extreme temperatures, so keeping it in a cool, dry place away from direct sunlight or heat sources is sufficient. No additional sterilization or special handling is needed before use.
Does the UltraSeal XT Plus require sterilization before application, and who can apply it?
No, the UltraSeal XT Plus is non-sterile and does not require sterilization before use. It must be prepared and applied by a dental professional following the manufacturer’s instructions. It is not intended for layperson use or self-application.
What regulatory pathways does the UltraSeal XT Plus follow in the U.S. and Europe?
In the U.S., the UltraSeal XT Plus is cleared through the FDA’s 510(k) premarket notification process (with clearance number K993846), demonstrating it is *substantially equivalent* to a predicate device. In Europe, it complies with the EU Medical Device Regulation (MDR) and is classified under regulatory code 872.3765, which categorizes it as a dental sealant, pit and fissure conditioner.
Are there different sizes or models of the UltraSeal XT Plus, or is it a single formulation?
The provided data does not specify multiple sizes or models of the UltraSeal XT Plus. It is described as a singular product designed for occlusal surfaces of molars and premolars, with no mention of variations in formulation, packaging, or application tools. For exact application details, refer to the manufacturer’s instructions.