Identifiers
- 510(k) Number
- K953272 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 Dentastic II is a dental adhesive cement classified under product code EMA, designed for bonding to multiple substrates including dentin, enamel, porcelain, resin, precious and non-precious metals, and amalgam. It is a dual-cure adhesive system intended to provide durable adhesion in restorative dentistry applications.
This device is supplied as a single-use system and is regulated under FDA 510(k) clearance (K953272) with a decision date of August 25, 1995. It falls under Class II with special controls and is intended for use in dental settings. No information regarding MRI safety or sterility is provided in the specifications.
Frequently asked questions
Is the Dentastic II adhesive cement intended for use with specific dental materials, and if so, which ones?
Yes, the Dentastic II is specifically designed for bonding to multiple dental substrates, including dentin, enamel, porcelain, resin, precious and non-precious metals, and amalgam. This versatility makes it suitable for a wide range of restorative dentistry applications where durable adhesion is required.
How is the Dentastic II adhesive cement supplied, and is it meant for single-use or reuse?
The Dentastic II is supplied as a single-use system, meaning each package is intended for one-time use only. This design ensures sterility and consistency in performance for each procedure.
Are there different sizes or models of the Dentastic II adhesive cement available, and how would I identify them?
The provided data lists multiple registration numbers (e.g., 3012441963, 3038718579) associated with the Dentastic II, which may correspond to different sizes, kits, or packaging configurations. While the exact variations aren’t detailed, these identifiers can help distinguish between them. For precise sizing or model-specific details, refer to the manufacturer’s documentation or contact Pulpdent Corporation directly.
Is there any information about how to store the Dentastic II adhesive cement to maintain its integrity?
The provided data does not specify storage instructions for the Dentastic II adhesive cement. For proper storage recommendations—such as temperature, humidity, or shelf life—consult the manufacturer’s instructions or packaging labels, as these details are critical to preserving the product’s performance and sterility.
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 DENTASTIC II (K953272) - FDA 510 (k), DenTASTIC® All Purpose - PULPDENT, PDF K953272 - Pulpdent Dentastic Ii, PULPDENT DENTASTIC II (K953272) — FDA 510 (k) | Innolitics, Pulpdent - Dentastic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K953272 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K953272 24 fields · synced Sep 18, 2026