ORTHODONITC ELASTOMERIC SLEEVING
FDA 510(k) clearance K943421 · decided 1995-05-23
Clearance details
- K-number
- K943421
- Device name
- ORTHODONITC ELASTOMERIC SLEEVING
- Applicant
- Jon-Ko Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-15
- Decision date
- 1995-05-23
- Days to decision
- 312 days
- Clearance type
- Traditional
- Product code
- DZD
- Device class
- 1
- Regulation number
- 872.5410
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Diego, CA, 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 |
|---|---|---|
| REGENCY TUBE (K936243) | Ortho Specialties | 1994-02-02 |
| DENTAURUM STAINLESS STEEL TUBING (K935143) | Dentauraum, Inc. | 1994-01-31 |
| NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) (K911399) | Aequitron Medical, Inc. | 1991-09-19 |
| RATE INCREASE FOR IPPB/IPV (K896586) | Percussionaire Corp. | 1990-01-09 |
| ALEXOTEK LINGUAL TUBES (K834446) | Alexotek Co. | 1984-04-05 |
| LABIAL CUSPID TUBE (K834392) | Alexotek Co. | 1984-02-28 |
| ORTHODONTIC BUCCAL TUBE (K780205) | Rocky Mountain Orthodontics, Inc. | 1978-02-16 |
Recalls involving this device
No recalls on record reference this clearance.