Identifiers
- 510(k) Number
- K972445 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulpdent Ox-Out is a Dental Cement, specifically a tinted, glycerine- and polyethylene glycol-based gel designed to inhibit oxygen exposure during the setting of anaerobic resin-type dental restorative materials. It prevents the formation of an oxygen-inhibited layer at restoration margins while accelerating polymerization for improved curing.
Supplied as a single-use gel, the device is intended for use in clinical dental settings during cementation procedures. It is classified as a Class II device under FDA regulations (product code EMA, regulation number 872.3275) and received FDA 510(k) clearance in 1997. No MRI safety or sterility specifications are noted in the regulatory data.
Frequently asked questions
What is the primary purpose of the Pulpdent Ox-Out in dental procedures?
The Pulpdent Ox-Out is a tinted, glycerine- and polyethylene glycol-based gel designed to prevent oxygen inhibition during the setting of anaerobic resin-type dental restorative materials. It inhibits oxygen exposure at restoration margins, which helps avoid the formation of an oxygen-inhibited layer and accelerates polymerization for improved curing.
Is the Pulpdent Ox-Out intended for single-use or repeated applications?
The Pulpdent Ox-Out is explicitly supplied as a single-use gel, meaning each application requires a new unit. This ensures sterility and consistency in clinical settings.
How should the Pulpdent Ox-Out be stored, and are there any special handling requirements?
The regulatory data does not specify sterility or MRI safety details for the Pulpdent Ox-Out, but as a single-use dental cement gel, it should be stored in a cool, dry place away from direct sunlight and extreme temperatures. Always follow manufacturer guidelines for optimal shelf life and integrity.
What regulatory pathway was followed for FDA clearance of the Pulpdent Ox-Out?
The Pulpdent Ox-Out received FDA 510(k) clearance in 1997 through a traditional review process, classified as a Class II dental cement under product code EMA. The submission was reviewed by the Dental (DE) Advisory Committee and determined to be substantially equivalent to a predicate device.
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 OX-OUT (K972445) — FDA 510 (k) | Innolitics, PULPDENT OX-OUT (K972445) - FDA 510 (k), PULPDENT ® Corporation - Advancing Dentistry Together
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972445 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K972445 24 fields · synced Sep 18, 2026