ORALCHEK SUPER-SOFT BRUSH
FDA 510(k) clearance K892264 · decided 1989-06-14
Clearance details
- K-number
- K892264
- Device name
- ORALCHEK SUPER-SOFT BRUSH
- Applicant
- Pfizer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-05
- Decision date
- 1989-06-14
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- EFW
- Device class
- 1
- Regulation number
- 872.6855
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Ny, NY, 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 |
|---|---|---|
| DENTEK EASY BRUSH WITH FLUORIDE (K130186) | Den Tek Oral Care, Inc. | 2013-07-15 |
| BEAM BRUSH/BEAM APP (K121165) | Beam Technologies, LLC | 2012-06-21 |
| SILVER CARE ANITBACTERIAL TOOTHBRUSH (K102871) | Piave Spazzolificio S.P.A. | 2011-10-03 |
| ORAL-B SUB-BRAND MANUAL TOOTHBRUSH (K073224) | Procter & Gamble | 2008-02-06 |
| ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL (K021383) | Agion Technologies, LLC | 2002-07-17 |
| MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS (K020776) | Coronet Group North America, LLC | 2002-06-03 |
| LAZERSMILE, LAZERWHITE (K000290) | Biolase Technology, Inc. | 2000-04-14 |
| TOOTHBRUSH WASH (K994144) | Cal Huech, Inc. | 2000-03-02 |
| BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER (K992435) | Azo Enterprises | 1999-10-15 |
| PLAQ-ATAQ-I (K980995) | Ethicare | 1998-08-20 |
| BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH (K974761) | John O. Butler Co. | 1998-06-16 |
| CREST TOOTHBRUSH WITH MICROSHIELD (K973236) | Procter & Gamble Co. | 1998-03-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP), (N18286/S041) | Pfizer, Inc. | 2023-05-16 |
| (Gelfoam (absorbable gelatin) Sterile Sponge) (N18286/S040) | Pfizer, Inc. | 2022-06-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S039) | Pfizer, Inc. | 2021-07-08 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S038) | Pfizer, Inc. | 2021-05-07 |
| Gelfoam Sterile Sponge (N18286/S037) | Pfizer, Inc. | 2021-02-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S036) | Pfizer, Inc. | 2020-12-10 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S035) | Pfizer, Inc. | 2020-03-19 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S034) | Pfizer, Inc. | 2020-02-27 |