A-COMPANY ELASTIC LIGATURE RINGS
FDA 510(k) clearance K852596 · decided 1985-07-31
Clearance details
- K-number
- K852596
- Device name
- A-COMPANY ELASTIC LIGATURE RINGS
- Applicant
- A Company, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-19
- Decision date
- 1985-07-31
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- ECI
- 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 |
|---|---|---|
| POWER COINS GLOW IN THE DARK LIGATURES (K980864) | Ortho Kinetics Corp. | 1998-04-20 |
| GLENROE CHAIN (K980053) | Glenroe Technologies | 1998-02-24 |
| GLENROE GLOW IN DARK ELASTOMERIC LIGATURES (K973495) | Glenroe | 1997-12-01 |
| ORTHODONTIC ELASTOMERIC LAGATURE MODULE (K943419) | Jon-Ko Products, Inc. | 1995-05-24 |
| ORTHODONTIC ELASTOMERIC CHAIN (K943420) | Jon-Ko Products, Inc. | 1995-05-23 |
| ORTHODONTIC ELASTOMERIC SEPARATOR MODULE (K943418) | Jon-Ko Products, Inc. | 1995-05-23 |
| ORTHODONTIC ELASTOMERIC TUBE/THREAD (K943417) | Jon-Ko Products, Inc. | 1995-05-23 |
| ALASTIK (K940165) | Unitek Corp. | 1994-03-07 |
| PRO'S NEO-LASTICS (K932298) | Professional Positioners, Inc. | 1994-02-14 |
| DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS (K935144) | Dentauraum, Inc. | 1994-02-04 |
| ORTHODONTIC ELASTOMER (K932319) | Gac Intl., Inc. | 1993-09-20 |
| GLENROE CHAIN (K931462) | Glenroe Technologies, Inc. | 1993-07-22 |
Recalls involving this device
No recalls on record reference this clearance.