510(k) K260376
- Device
- Denture Base
- Applicant
- Shandong Huge Dental Material Corporation
- 510(k) number
- K260376
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-06
- Date received
- 2026-02-05
- Regulation
- 872.3760
- Classification name
- Resin, Denture, Relining, Repairing, Rebasing
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Zheng Maggie
- Address
- # 68 Shanhai Rd., Donggang District Rizhao City CN 276800 276800
FDA Registration Numbers
- 3008912871
- 9681199
- 3022545323
- 3032727
- 9680144
- 3005343849
- 3010368334
- 1000303432
- 9612300
- 2950685
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- 3033085428
- 2032807
- 2081055
- 1000277456
- 8030870
Source Documents
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| K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-03-31 |
| K243103 | Denture Base | Riton 3D Technology Co., Ltd. | 2024-12-23 |
| K243336 | Lucitone Digital Print DentureĀ System | Dentsply Sirona, Inc. | 2024-12-17 |
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| K241089 | KeyPrint KeyDenture Base | Keystone Industries | 2024-10-24 |