510(k) K250015
- Device
- Ormco? EtchFree Bonding System, Ormco? EtchFree Bonding Primer, Ormco? EtchFree Adhesive
- Applicant
- Ormco Corporation
- 510(k) number
- K250015
- Product code
- DYH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-03
- Date received
- 2025-01-02
- Regulation
- 872.3750
- Classification name
- Adhesive, Bracket And Tooth Conditioner, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Related Records
Applicant Contact
- Contact
- Tara Bonny
- Address
- 200 S. Kraemer Blvd. Brea CA US 92821 92821
FDA Registration Numbers
- 3002807050
- 3032763783
- 1410097
- 3008912871
- 3003622434
- 3004109528
- 1215305
- 1420052
- 3015272949
- 9612300
- 3022296393
- 8010908
- 3010065389
- 1815540
- 2511556
- 1000118628
- 3008005217
- 9680845
- 1420089
- 1413475
- 1718476
- 3031841433
- 2024980
- 2022039
- 3038718579
- 2126683
- 3004158247
- 3032163716
- 9681210
- 3008524225
- 3007113445
- 3010864832
- 1000272892
- 3006805063
- 3014683120
- 3010032042
- 3032027578
- 3007210751
- 3032378317
- 2018957
- 3016543896
- 1721647
- 9611458
- 3004130302
- 3012187973
- 3008882689
- 3042272797
- 3027241817
- 3012996495
- 3007584711
- 3012494290
- 1450653
- 3012421607
- 1424442
- 1718912
- 2024312
- 2023950
- 3013410675
- 3006697692
- 2027375
- 9613953
Source Documents
Other 510(k) Records For Product Code DYH
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242537 | BracePaste Fluoride Sealant | American Orthodontics Corp. | 2024-08-27 |
| K234043 | 3M™ Transbond™ Orthodontic Adhesive | 3M Unitek Orthodontic Products | 2023-12-22 |
| K231817 | AlignerFlow LC | Voco GmbH | 2023-12-01 |
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | Tp Orthodontics, Inc. | 2022-10-14 |
| K210115 | FiteBac CC OrthoSeal | Largent Health, LLC | 2021-07-29 |
| K202276 | BracePaste Band and Build LC | American Orthodontics | 2020-08-14 |
| K192682 | Orthocem, Ortho Bite | Dentscare Ltda | 2020-08-14 |
| K193388 | GlassLok Kits, GlassLok Powder, GlassLok Liquid | Reliance Orthodontic Products, Inc. | 2020-04-27 |
| K183147 | BrackFix | Voco GmbH | 2019-03-01 |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | Pulpdent Corporation | 2018-01-17 |
| K160782 | BracePaste Adhesive | American Orthodontics | 2016-10-14 |
| K161684 | Quantum LB | Reliance Orthodontic Products, Inc. | 2016-10-06 |
| K150128 | GC Ortho Connect, GC Ortho Etching Gel | Gc Orthodontics America, Inc. | 2015-07-16 |
| K143667 | GC KommonBase | Gc Orthodontics America, Inc. | 2015-05-07 |
| K142886 | DMRC Self-Cure Bracket Adhesive One Step and Primer | Danville Materials, LLC | 2015-03-18 |