LED PRO SEAL
FDA 510(k) clearance K073243 · decided 2008-02-08
Clearance details
- K-number
- K073243
- Device name
- LED PRO SEAL
- Applicant
- Reliance Orthodontic Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-11-19
- Decision date
- 2008-02-08
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- EBD
- Device class
- 2
- Regulation number
- 872.3310
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Itasca, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Reliance Orthodontic Products
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 |
|---|---|---|
| GLOSSY COAT (15ML) (K254091) | YAMAHACHI DENTAL MFG., Co. | 2026-04-06 |
| ID LIGHT CURE SYSTEM (K250804) | Id Korea Co., Ltd. | 2025-06-04 |
| visio.lign color, visio.lign shield (K240735) | Bredent GmbH & Co. KG | 2024-12-12 |
| RODIN Palette Naturalizing Kit (K223365) | Belport Company, Inc., Gingi-Pak | 2023-03-27 |
| VITA Akzent LC (K211854) | Vita Zahnfabrik GmbH H Rauter & CO | 2021-11-22 |
| Nano Varnish, Plaquit, Lightpaint on Surface (K162408) | Dreve Dentamid GmbH | 2018-04-05 |
| SHOFU RESIN GLAZE (K163568) | Shofu Dental Corporation | 2017-08-16 |
| OPTIGLAZE COLOR (K133836) | GC America, Inc. | 2014-03-06 |
| VITA ENAMIC STAINS (K123761) | Innovation Meditech GmbH | 2013-03-01 |
| ENAMELITE ACRYSEAL SPRAY SEALANT (K093019) | Enamelite, LLC | 2009-12-22 |
| EASY GLAZE (K082285) | Voco GmbH | 2008-10-24 |
| DURAFINISH ALL-CURE, MODEL S296 (K080549) | Parkell, Inc. | 2008-05-13 |
Recalls involving this device
No recalls on record reference this clearance.