DENCLENZ
FDA 510(k) clearance K854995 · decided 1986-05-12
Clearance details
- K-number
- K854995
- Device name
- DENCLENZ
- Applicant
- Creighton Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-12
- Decision date
- 1986-05-12
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- EFT
- Device class
- 1
- Regulation number
- 872.3520
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- New York, 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 |
|---|---|---|
| CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER (K080631) | Oral Health Technologies, LLC | 2008-05-23 |
| MEDICAL INTERPOROUS (K051342) | Bonyf AG | 2006-06-02 |
| TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND (K000996) | Dentsply Intl. | 2000-06-16 |
| OTC DENTURE CLEANSER (K942203) | Combe, Inc. | 1994-08-10 |
| PROFAST(R)-DENTURE CLEANSER (K930337) | Fittydent-Altwirth & Schmitt GmbH | 1993-09-07 |
| DENTURE PRODUCT X (K914257) | Essential Dental Systems, Inc. | 1993-01-13 |
| CFR MONOGRAPH (K925259) | Combe, Inc. | 1993-01-11 |
| DENTURE DYNAMIC'S DENTURE MAGIC (K902838) | Denture Dynamic'S, Inc. | 1990-09-06 |
| ARGILITE 4 GOLD ALLOY FOR PORCELAIN (K903686) | Argen Precious Metals, Inc. | 1990-08-29 |
| ORAD TOOTHBRUSH CLEANER (K895345) | Orad, Inc. | 1990-03-07 |
| DENTCLEAN CONCENTRATED DENTURE CLEANSER (K890043) | K-P Co. | 1989-06-07 |
| CLEAN DENT (K890668) | Lincoln Park Dental Laboratory | 1989-04-17 |
Recalls involving this device
No recalls on record reference this clearance.