510(k) K243336
- Device
- Lucitone Digital Print Denture System
- Applicant
- Dentsply Sirona, Inc.
- 510(k) number
- K243336
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-17
- Date received
- 2024-10-24
- 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
- Melanie Avila
- Address
- 221 W. Philadelphia St. Suite 60w York PA US 17401 17401
FDA Registration Numbers
- 3008912871
- 9681199
- 3022545323
- 3032727
- 9680144
- 3005343849
- 3010368334
- 1000303432
- 9612300
- 2950685
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- 3009312537
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- 2515379
- 3033085428
- 2032807
- 2081055
- 1000277456
- 8030870
Source Documents
Other 510(k) Records For Product Code EBI
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|---|---|---|---|
| K260376 | Denture Base | Shandong Huge Dental Material Corporation | 2026-05-06 |
| K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | 2025-11-25 |
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| K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | 2025-11-20 |
| K252430 | Freeprint® denture flex | Detax GmbH | 2025-10-30 |
| K252035 | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) | Kamemizu Chemical Industry Co., Ltd. | 2025-09-17 |
| K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | 2025-06-25 |
| K242897 | Partial Flex | Clemde SA DE CV | 2025-06-03 |
| K250489 | FP3D | Keystone Industries | 2025-05-20 |
| K250617 | Apex Flex | Sprintray, Inc. | 2025-04-29 |
| K243356 | Asiga DentaBASE | Asiga Pty, Ltd. | 2025-04-11 |
| 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 |
| K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024-11-22 |
| K241089 | KeyPrint KeyDenture Base | Keystone Industries | 2024-10-24 |