Product code ECI
- Device name
- Band, Elastic, Orthodontic
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.5410
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K980864 | POWER COINS GLOW IN THE DARK LIGATURES | Ortho Kinetics Corp. | 1998-04-20 |
| K980053 | GLENROE CHAIN | Glenroe Technologies | 1998-02-24 |
| K973495 | GLENROE GLOW IN DARK ELASTOMERIC LIGATURES | Glenroe | 1997-12-01 |
| K943419 | ORTHODONTIC ELASTOMERIC LAGATURE MODULE | Jon-Ko Products, Inc. | 1995-05-24 |
| K943417 | ORTHODONTIC ELASTOMERIC TUBE/THREAD | Jon-Ko Products, Inc. | 1995-05-23 |
| K943418 | ORTHODONTIC ELASTOMERIC SEPARATOR MODULE | Jon-Ko Products, Inc. | 1995-05-23 |
| K943420 | ORTHODONTIC ELASTOMERIC CHAIN | Jon-Ko Products, Inc. | 1995-05-23 |
| K940165 | ALASTIK | Unitek Corp. | 1994-03-07 |
| K932298 | PRO'S NEO-LASTICS | Professional Positioners, Inc. | 1994-02-14 |
| K935144 | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS | Dentauraum, Inc. | 1994-02-04 |
| K932319 | ORTHODONTIC ELASTOMER | Gac Intl., Inc. | 1993-09-20 |
| K931462 | GLENROE CHAIN | Glenroe Technologies, Inc. | 1993-07-22 |
| K923999 | ALASTIK NS | Unitek Corp. | 1993-06-24 |
| K930453 | SINGLES | Nexadental | 1993-05-27 |
| K924140 | TUFF TIES | Glenroe Technologies | 1993-04-27 |
| K924139 | GLENROE ORTHO SEPS | Glenroe Technologies | 1993-04-08 |
| K926578 | UNI-STICK PLASTIC LIGATURE, MODIFIED | American Orthodontics | 1993-03-31 |
| K882695 | RUBBER BAND, STERILE | Bioseal | 1988-10-13 |
| K852596 | A-COMPANY ELASTIC LIGATURE RINGS | A Company, Inc. | 1985-07-31 |
| K852597 | A-COMPANY ELASTIC ROTATION WEDGES | A Company, Inc. | 1985-07-31 |
| K852598 | A-COMPANY SEPARATING ELASTICS | A Company, Inc. | 1985-07-31 |
| K852599 | A-COMPANY ELASTOMERIC TUBING | A Company, Inc. | 1985-07-31 |
| K852600 | A-COMPANY ELASTOMERIC CHAIN DISPENSER | A Company, Inc. | 1985-07-31 |
| K810010 | ORTHODONTIC ELASTICS | Orec Corp. | 1981-01-28 |
| K780804 | HYGIENIC ANCHORINGS | Hygienic Dental Mfg., Co., The | 1978-06-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07895742258757 | Morelli | Dental Morelli Ltda | 2021-05-03 |
| 07895742258764 | Morelli | Dental Morelli Ltda | 2021-05-03 |
| 07895742077365 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742113001 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077976 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077969 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077952 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077488 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077471 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077464 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077457 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077433 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077426 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077419 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077402 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077389 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077372 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742188740 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742077358 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742005528 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742005511 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742005504 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742005498 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742005481 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742005474 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742188849 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742188818 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742188795 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| J011772204020 | N.A. | DENTAURUM GmbH & Co.KG | 2021-03-10 |
| J011772208010 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |