BARRIER ALL FILM
FDA 510(k) clearance K952234 · decided 1995-07-31
Clearance details
- K-number
- K952234
- Device name
- BARRIER ALL FILM
- Applicant
- Cottrell, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-12
- Decision date
- 1995-07-31
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- EFS
- Device class
- 1
- Regulation number
- 872.6510
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (K023232) | Smartpractice | 2002-12-11 |
| DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 (K001493) | Air Force, Inc. | 2000-10-25 |
| AGATHA-A-H2010 (K983374) | Midian Intl. | 1998-12-23 |
| DERMADAM (K964810) | Ultradent Products, Inc. | 1997-02-10 |
| ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (K943182) | Oral-B Laboratories | 1994-09-09 |
| PERIOFLEX TIP (K923711) | Novadent, Ltd. | 1994-05-16 |
| HYDRO FLOSS (K923937) | Hydro Floss, Inc. | 1994-02-25 |
| WATER PIK PLUS PLAQUE CONTROL SYSTEM (K931380) | Teledyne Water Pik | 1993-09-20 |
| SHOWERFLOSS (K923457) | Summit Marketing Group, Inc. | 1992-09-01 |
| SHOWERFLOSS ORAL IRRIGATION UNIT (K922307) | Showerfloss, Inc. | 1992-06-16 |
| INTERJET(TM) GINGIVAL CARE INSTRUMENT (K921999) | Bausch & Lomb, Inc. | 1992-06-03 |
| MAX-I-PROBE IRRIGATION SYSTEM (K913030) | Smith & Nephew, Inc. | 1991-09-30 |
Recalls involving this device
No recalls on record reference this clearance.