Identifiers
- 510(k) Number
- K963921 FDA 510(k)
- FDA Product Code
- EBC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3765 FDA 510(k)
- Regulation Number
- 872.3765 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Seal-Rite UDMA is a Pit and Fissure Sealant and Conditioner, designed to protect dental enamel by sealing occlusal surfaces against caries. It is formulated as a radiopaque, visible-light-cured material that adheres to tooth structures, reducing the risk of decay in susceptible areas.
This device is supplied as a single-use, non-sterile dental material intended for use in clinical settings by dental professionals. It is available in multiple formulations, including variations with and without fluoride, and is compliant with ANSI/ADA Specification No. 39. The product is regulated under FDA 510(k) clearance (K963921) and falls under the Dental category (EBC product code).
Frequently asked questions
What is the primary purpose of the Pulpdent Seal-Rite UDMA and how does it work?
The Pulpdent Seal-Rite UDMA is a pit and fissure sealant and conditioner designed to protect dental enamel by sealing occlusal surfaces against caries (tooth decay). It is a radiopaque, visible-light-cured material that adheres directly to tooth structures, creating a protective barrier in areas prone to bacterial invasion and acid erosion. This helps reduce the risk of cavities in susceptible regions of the teeth.
Is the Seal-Rite UDMA available in multiple formulations, and what distinguishes them?
Yes, the Seal-Rite UDMA is available in multiple formulations, including variations with and without fluoride. The fluoride-containing versions provide an additional preventive benefit by helping remineralize enamel and further reduce decay risk. Both types adhere to teeth via visible light curing and comply with ANSI/ADA Specification No. 39 for dental sealants.
How is the Seal-Rite UDMA supplied, and is it intended for single-use or reuse?
The Seal-Rite UDMA is supplied as a single-use, non-sterile dental material, intended exclusively for clinical use by dental professionals. Since it is non-sterile and designed for one-time application per patient, it must be discarded after use to maintain infection control standards. This aligns with standard practices for dental restorative materials.
What storage conditions should be followed for the Seal-Rite UDMA to ensure proper performance?
While the exact storage instructions are not detailed in the provided data, typical recommendations for visible-light-cured dental sealants like this one include storing in a cool, dry place (e.g., 15–25°C or 59–77°F) and protecting from direct sunlight or extreme temperatures. Since it is non-sterile and single-use, it should also be kept in its original packaging until ready for use to prevent contamination.
What regulatory pathway does the Seal-Rite UDMA follow, and how is it classified?
The Seal-Rite UDMA is regulated under the FDA 510(k) clearance pathway, specifically classified as Substantially Equivalent (SESE) to a predicate device. It falls under the Dental category (EBC product code) and was originally cleared in 1996 (K-number: K963921). The device is also categorized as Class II under the FDA’s medical device classification system, indicating it carries moderate risk and requires pre-market notification.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PULPDENT SEAL-RITE UDMA by PULPDENT CORP. | FDA 510(k) Summary, Seal-Rite™ Pit & Fissure Sealant - PULPDENT, PULPDENT SEAL-RITE UDMA (K963921) — FDA 510(k) | Innolitics, PULPDENT SEAL-RITE UDMA (K963921) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K963921 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K963921 24 fields · synced Sep 18, 2026