Barrier All Film
FDA 510(k) K952234 · Cottrell, Ltd.
510(k) numberK952234
Submission
- Device name
- Barrier All Film
- Applicant
- Cottrell, Ltd.
North Attleboro, MA, US - Received
- May 12, 1995
- Decision date
- July 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K001493 | Dental Air Force Home Dental Cleaning System, Model No. 0020001EFS · Traditional | Air Force, Inc. | 10/25/2000SE |
| K983374 | AGATHA-A-H2010EFS · Traditional | Midian Intl. | 12/23/1998SE |
| K964810 | DermadamEFS · Traditional | Ultradent Products, Inc. | 02/10/1997SE |
| K943182 | Oral-B Perioflex Subgingival IrrigatorEFS · Traditional | Oral-B Laboratories | 09/09/1994SE |
| K923711 | Perioflex TipEFS · Traditional | Novadent, Ltd. | 05/16/1994SE |
| K923937 | Hydro FlossEFS · Traditional | Hydro Floss, Inc. | 02/25/1994SE |
| K931380 | Water Pik Plus Plaque Control SystemEFS · Traditional | Teledyne Water Pik | 09/20/1993SE |
| K923457 | ShowerflossEFS · Traditional | Summit Marketing Group, Inc. | 09/01/1992SE |
| K922307 | Showerfloss Oral Irrigation UnitEFS · Traditional | Showerfloss, Inc. | 06/16/1992SE |
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| K952241 | Protouch OvergloveMMP · Traditional | 08/07/1995SE |
| K932922 | Procide 14 N.S., Omnicide/Liquid & Plus Liq ActivatorMED · Traditional | 07/03/1995SE |
| K951983 | Imni-IiLRJ · Traditional | 06/20/1995SE |
| K945575 | Pro Barrier(Tm) Tube Sox(Tm)MMN · Traditional | 03/06/1995SE |
| K893802 | Proview Self-Sealing Sterilization PouchKCT · Traditional | 04/04/1990SE |
Questions and answers
When was Barrier All Film cleared by the FDA?
Barrier All Film (K952234) received a 510(k) decision of Substantially Equivalent on July 31, 1995, 80 days after the submission was received.
What is the product code of K952234?
The FDA product code is EFS – Unit, Oral Irrigation, a Class I (low risk) device regulated under 21 CFR 872.6510.