Identifiers
- 510(k) Number
- K901051 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 22% Polyacrylic Acid Gel is a thixotropic dental conditioning agent classified as a dentin conditioning gel (Product Code: EBF). It is designed to remove the smear layer from dentin, preparing the surface for bonding or cementation procedures in restorative dentistry. This gel facilitates improved adhesion of glass ionomer cements and other dentin bonding materials by chemically conditioning the dentin substrate.
Supplied in a 1.2 mL syringe kit (4 syringes per box, including 8 prebent dispenser needles), the gel is intended for single-use in clinical settings. It is not sterile as packaged but is intended for use in aseptic conditions. The device holds FDA 510(k) clearance (K901051) under the Traditional review pathway, with no third-party certification noted. Storage should follow manufacturer guidelines to maintain product integrity.
Frequently asked questions
What is the primary purpose of the 22% Polyacrylic Acid Gel in dental procedures?
The 22% Polyacrylic Acid Gel is specifically designed to remove the smear layer from dentin, which is the calcified tissue beneath the enamel. This conditioning process prepares the dentin surface for better adhesion of restorative materials like glass ionomer cements or other bonding agents, ensuring stronger and more reliable bonding during procedures such as fillings or crown preparations.
How is the 22% Polyacrylic Acid Gel supplied, and is it intended for single-use?
The gel comes in a 1.2 mL syringe kit, with each box containing four syringes and eight prebent dispenser needles. It is explicitly intended for single-use in clinical settings, meaning each syringe should be discarded after one application to maintain sterility and safety. The product is not sterile as packaged, so it must be used under aseptic conditions.
What storage instructions should be followed to keep the 22% Polyacrylic Acid Gel effective?
While the exact storage details are not specified in the data, the manufacturer recommends adhering to their guidelines to preserve the product’s integrity. Generally, dental gels like this should be stored in a cool, dry place away from direct sunlight and extreme temperatures. Always check the packaging for any specific storage conditions, such as refrigeration or room-temperature storage, to ensure optimal performance.
Is this device regulated by the FDA, and if so, what type of review pathway was used?
Yes, the 22% Polyacrylic Acid Gel holds FDA 510(k) clearance (K901051) under the Traditional review pathway. This means the manufacturer demonstrated that their device is substantially equivalent to a legally marketed predicate device already on the market. The clearance was granted by the Dental (DE) Advisory Committee in 1990, with no third-party certification involved.
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: Dentin Conditioning Gel™ - PULPDENT, DEN Dentin Conditioning Gel - Henry Schein Dental, Dentin Conditioning Gel - 22% Polyacrylic Acid - Pulpdent | Alpine Dental, Pulpdent Dentin Conditioning Gel 22% Polyacrylic Acid, Kit: 4 - 1.2 ml ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K901051 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K901051 24 fields · synced Sep 18, 2026