Autopack Non-Eugenol Periodontal Dressing
FDA 510(k) K913572 · Specialites Septodont
510(k) numberK913572
Submission
- Device name
- Autopack Non-Eugenol Periodontal Dressing
- Applicant
- Specialites Septodont
Washington, DC, US - Received
- August 12, 1991
- Decision date
- October 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EMA
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|---|---|---|---|
| K254201 | Any-CemEMA · Traditional | Mediclus Co., Ltd. | 08/13/2026SE |
| K261937 | PacTemp Automix NEEMA · Traditional | The Belport Company Inc., DBA Gingi-Pak | 08/07/2026SE |
| K261166 | Dia-CemEMA · Traditional | DiaDent Group International | 07/09/2026SE |
| K254109 | G-Cem UniversalEMA · Traditional | GC America, Inc. | 05/18/2026SE |
| K253337 | REGEN Bioactive CementEMA · Traditional | Inter-Med, Inc. | 04/15/2026SE |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional | Voco GmbH | 03/20/2026SE |
| K254063 | iCEM Universal PlusEMA · Abbreviated | Kulzer, LLC | 12/19/2025SE |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin CementEMA · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/12/2025SE |
| K252808 | GlasIonomer FX-LCEMA · Traditional | Shofu Dental Corporation | 12/09/2025SE |
| K252165 | Zirconomer PEMA · Traditional | Shofu Dental Corporation | 10/28/2025SE |
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| K982773 | Quickset Liquid and PowderEMA · Traditional | 11/03/1998SE |
| K982671 | SecuralloyEJJ · Traditional | 10/19/1998SE |
| K980633 | Endosolv EKIF · Traditional | 05/01/1998SE |
| K920692 | Septocalcine UltraEJK · Traditional | 04/21/1992SE |
| K915467 | Cimpat S Dental CementEMA · Traditional | 02/03/1992SE |
| K915466 | Septopack Temporary FillingEBG · Traditional | 02/03/1992SE |
| K913573 | Safety Plus Dental Injection NeedleDZM · Traditional | 11/07/1991SE |
| K913574 | Septocal Cavity LinerEJK · Traditional | 09/30/1991SE |
Questions and answers
When was Autopack Non-Eugenol Periodontal Dressing cleared by the FDA?
Autopack Non-Eugenol Periodontal Dressing (K913572) received a 510(k) decision of Substantially Equivalent on October 9, 1991, 58 days after the submission was received.
What is the product code of K913572?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.