FDA Product Code
FDA Product Code ECI — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5410
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K980864 | POWER COINS GLOW IN THE DARK LIGATURES | Ortho Kinetics Corp. | 1998-04-20 | Traditional | PDF ↗ |
| K980053 | GLENROE CHAIN | Glenroe Technologies | 1998-02-24 | Traditional | PDF ↗ |
| K973495 | GLENROE GLOW IN DARK ELASTOMERIC LIGATURES | Glenroe | 1997-12-01 | Traditional | PDF ↗ |
| K943419 | ORTHODONTIC ELASTOMERIC LAGATURE MODULE | Jon-Ko Products, Inc. | 1995-05-24 | Traditional | PDF ↗ |
| K943418 | ORTHODONTIC ELASTOMERIC SEPARATOR MODULE | Jon-Ko Products, Inc. | 1995-05-23 | Traditional | PDF ↗ |
| K943420 | ORTHODONTIC ELASTOMERIC CHAIN | Jon-Ko Products, Inc. | 1995-05-23 | Traditional | PDF ↗ |
| K943417 | ORTHODONTIC ELASTOMERIC TUBE/THREAD | Jon-Ko Products, Inc. | 1995-05-23 | Traditional | PDF ↗ |
| K940165 | ALASTIK | Unitek Corp. | 1994-03-07 | Traditional | PDF ↗ |
| K932298 | PRO'S NEO-LASTICS | Professional Positioners, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K935144 | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS | Dentauraum, Inc. | 1994-02-04 | Traditional | PDF ↗ |
| K932319 | ORTHODONTIC ELASTOMER | Gac Intl., Inc. | 1993-09-20 | Traditional | PDF ↗ |
| K931462 | GLENROE CHAIN | Glenroe Technologies, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K923999 | ALASTIK NS | Unitek Corp. | 1993-06-24 | Traditional | PDF ↗ |
| K930453 | SINGLES | Nexadental | 1993-05-27 | Traditional | PDF ↗ |
| K924140 | TUFF TIES | Glenroe Technologies | 1993-04-27 | Traditional | PDF ↗ |
| K924139 | GLENROE ORTHO SEPS | Glenroe Technologies | 1993-04-08 | Traditional | PDF ↗ |
| K926578 | UNI-STICK PLASTIC LIGATURE, MODIFIED | American Orthodontics | 1993-03-31 | Traditional | PDF ↗ |
| K882695 | RUBBER BAND, STERILE | Bioseal | 1988-10-13 | Traditional | PDF ↗ |
| K852600 | A-COMPANY ELASTOMERIC CHAIN DISPENSER | A Company, Inc. | 1985-07-31 | Traditional | PDF ↗ |
| K852597 | A-COMPANY ELASTIC ROTATION WEDGES | A Company, Inc. | 1985-07-31 | Traditional | PDF ↗ |
| K852596 | A-COMPANY ELASTIC LIGATURE RINGS | A Company, Inc. | 1985-07-31 | Traditional | PDF ↗ |
| K852598 | A-COMPANY SEPARATING ELASTICS | A Company, Inc. | 1985-07-31 | Traditional | PDF ↗ |
| K852599 | A-COMPANY ELASTOMERIC TUBING | A Company, Inc. | 1985-07-31 | Traditional | PDF ↗ |
| K810010 | ORTHODONTIC ELASTICS | Orec Corp. | 1981-01-28 | Traditional | PDF ↗ |
| K780804 | HYGIENIC ANCHORINGS | Hygienic Dental Mfg., Co., The | 1978-06-14 | Traditional | PDF ↗ |
Product code ECI · Class I · Dental. Data: openFDA.