Fastdam
FDA 510(k) K972775 · Interdent, Inc.
510(k) numberK972775
Submission
- Device name
- Fastdam
- Applicant
- Interdent, Inc.
Los Angeles, CA, US - Received
- July 24, 1997
- Decision date
- February 27, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EIE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182118 | armor LCEIE · Traditional | Mavrik Dental Systems, Ltd. | 05/03/2019SE |
| K151945 | Triumph Resin DamEIE · Traditional | Denali Corporation | 02/18/2016SE |
| K050318 | Bari-Kad Packing DeviceEIE · Traditional | Bioenvelop Agro, Inc. | 03/04/2005SE |
| K043301 | GC Tion Gingival ProtectorEIE · Traditional | GC America, Inc. | 01/25/2005SE |
| K040797 | Britesmile Masking CreamEIE · Special | Britesmile, Inc. | 04/02/2004SE |
| K022522 | Pulpdent Putty DamEIE · Traditional | Pulpdent Corporation | 09/26/2002SE |
| K021524 | Light Cure Dental DamEIE · Traditional | Prime Dental Manufacturing, Inc. | 07/19/2002SE |
| K021613 | Niveous Liquid DamEIE · Traditional | Shofu Dental Corp. | 06/20/2002SE |
| K010935 | Britesmile Barrier MaterialEIE · Traditional | Britesmile, Inc. | 09/05/2001SE |
| K983227 | Power BlockEIE · Traditional | Kreativ, Inc. | 12/11/1998SE |
More from Kreativ, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K823457 | Non-Pressure Autoclave for SterilizationFLE · Traditional | 02/23/1983SE |
Questions and answers
When was Fastdam cleared by the FDA?
Fastdam (K972775) received a 510(k) decision of Substantially Equivalent on February 27, 1998, 218 days after the submission was received.
What is the product code of K972775?
The FDA product code is EIE – Dam, Rubber, a Class I (low risk) device regulated under 21 CFR 872.6300.