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Autopack Non-Eugenol Periodontal Dressing

FDA 510(k)

Class II (US FDA 510(k))

510(k) K913572

by Specialites Septodont

Identifiers

510(k) Number
K913572 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 Autopack Non-Eugenol Periodontal Dressing is a dental cement dressing classified under the category of Cement, Dental. It is designed as a non-eugenol periodontal dressing, intended for application in periodontal pockets to promote healing and protect surgical sites following periodontal procedures. This sterile, single-use product is formulated to provide a protective barrier while minimizing patient discomfort and irritation.

This dressing is supplied in sterile, pre-packaged form for direct clinical use in dental settings. It is classified as a Class II device under FDA regulations (872.3275) and holds a 510(k) clearance (K913572) for substantial equivalence. The product is intended for single-use only and must be stored according to manufacturer guidelines to maintain sterility and efficacy. No MRI safety information is specified, and its use is restricted to dental professionals in controlled clinical environments.

Frequently asked questions

What is the Autopack Non-Eugenol Periodontal Dressing used for?

The Autopack Non-Eugenol Periodontal Dressing is designed specifically for application in periodontal pockets to create a protective barrier over surgical sites following periodontal procedures. Its purpose is to promote healing while minimizing patient discomfort and irritation, ensuring a stable environment for tissue recovery.

How is the Autopack Non-Eugenol Periodontal Dressing supplied?

This product is supplied in sterile, pre-packaged form, ready for immediate clinical use. Each package is individually sealed to maintain sterility until opened, ensuring safety and reliability in dental settings.

Is the Autopack Non-Eugenol Periodontal Dressing intended for single-use or reuse?

The Autopack Non-Eugenol Periodontal Dressing is explicitly intended for single-use only. Reusing it could compromise sterility and patient safety, so it must be discarded after one application.

What storage guidelines should be followed to maintain its efficacy?

To preserve sterility and effectiveness, the dressing must be stored according to the manufacturer’s guidelines. This typically includes keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains unopened until use.

Is there any specific safety information regarding MRI compatibility for this dressing?

The manufacturer does not specify MRI safety information for the Autopack Non-Eugenol Periodontal Dressing. As a result, its use should be restricted to dental professionals in controlled clinical environments where MRI exposure is not a concern.

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: AUTOPACK NON-EUGENOL PERIODONTAL DRESSING (K913572) — FDA 510(k ..., AUTOPACK NON-EUGENOL PERIODONTAL DRESSING 510(k)… - FDA.report, AUTOPACK NON-EUGENOL PERIODONTAL DRESSING 510(k)… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Specialites Septodont

Sources (1)

  • FDA 510(k) K913572 24 fields · synced Oct 1, 2026