PERLIDENT
FDA 510(k) clearance K894933 · decided 1989-10-12
Clearance details
- K-number
- K894933
- Device name
- PERLIDENT
- Applicant
- Germiphene Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-03
- Decision date
- 1989-10-12
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- EJR
- Device class
- 1
- Regulation number
- 872.6030
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Brantford Ontario, CA
- 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 |
|---|---|---|
| AIR-FLOW PLUS Prophylaxis powder (K171189) | E.M.S Electro Medical Systems S.A | 2017-09-11 |
| WHIP MIX PREPPIES PLUS (K131760) | Whip-Mix Corp. | 2014-03-26 |
| NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN (K121698) | Dentsply International, Inc. | 2012-08-06 |
| OSSPRAY SYLC CR (K103114) | Osspray, Ltd. | 2011-03-14 |
| BUTLER CALCI-FLOR PROPHYLAXIS PASTE (K102053) | Sunstar Americas, Inc. | 2011-02-03 |
| REMIN PRO (K101104) | Voco GmbH | 2010-10-21 |
| PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE (K100539) | Preventive Technologies, Inc. | 2010-06-17 |
| GC MI PASTE PLUS (K070854) | GC America, Inc. | 2007-04-12 |
| OSSPRAY CLEANING COMPOUND (K062502) | Ospray, Ltd. | 2006-12-15 |
| ENAMEL PRO (K062166) | Premier Dental Products Co. | 2006-11-21 |
| GELATO PROPHYLAXIS PASTE (K042048) | Deepak Products, Inc. | 2004-10-26 |
| MI PASTE (K042200) | GC America, Inc. | 2004-10-20 |
Recalls involving this device
No recalls on record reference this clearance.