REGENCY TUBE
FDA 510(k) clearance K936243 · decided 1994-02-02
Clearance details
- K-number
- K936243
- Device name
- REGENCY TUBE
- Applicant
- Ortho Specialties
- Decision
- Substantially Equivalent
- Date received
- 1993-12-30
- Decision date
- 1994-02-02
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- DZD
- Device class
- 1
- Regulation number
- 872.5410
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hickory Hills, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ortho Specialties
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ORTHODONITC ELASTOMERIC SLEEVING (K943421) | Jon-Ko Products, Inc. | 1995-05-23 |
| 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.