510(k) K011762
- Device
- HI-WAVE; POUR-PLUS
- Applicant
- DENPLUS, INC.
- 510(k) number
- K011762
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-23
- Date received
- 2001-06-07
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHUOJIA DONG
- Address
- 1221 Labadie, Suite 205 Longueuil, Quebec CA J4N 1E2 J4N 1E2
FDA Registration Numbers#
- 3032727
- 1038806
- 2523320
- 3010368334
- 3005350578
- 3039433962
- 2515379
- 2133714
- 3015674635
- 1316408
- 3009312537
- 3010564008
- 3003621174
- 9613953
- 3020841418
- 3010664129
- 4565
- 3009482106
- 9681199
- 3003928050
- 3013551048
- 9710611
- 3043226252
- 3024749697
- 3011511773
- 3016237718
- 9681531
- 2087259
- 3040605150
- 1000303432
- 1420052
- 3023346365
- 3014270094
- 3013343038
- 3016074824
- 3012389497
- 1417322
- 3017374693
- 8044164
- 3005344553
- 9680348
- 3004130302
- 3008569063
- 1410097
- 2183301
- 3008254125
- 1223843
- 8030870
- 2081055
- 3010002722
- 8021851
- 3011649314
- 3021024355
- 3022545323
- 3012494290
- 3005598536
- 3030515618
- 3015491441
- 8030452
- 1415367
- 1483306
- 9610902
- 1000243214
- 3003231822
- 3008494285
- 1000625496
- 1000486347
- 2921595
- 3004935484
- 3003756493
- 9681356
- 1221541
- 3005459236
- 3030686055
- 1416675
- 3004905070
- 3008320092
- 3022068322
- 3011532731
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261802 | Glidewell™ Denture Base Resin | Prismatik Dentalcraft, Inc. | 2026-08-27 |
| K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | 2026-08-13 |
| K262681 | NanoCeram Resin | 3BFAB TEKNOLOJI A.S. | 2026-07-31 |
| K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026-07-08 |
| K261474 | DENTCA Tru Flexible | Dentca, Inc. | 2026-07-01 |
| K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | 2026-06-02 |
| K260376 | Denture Base | Shandong Huge Dental Material Corporation | 2026-05-06 |
| K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | 2025-11-25 |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) | Graphy, Inc. | 2025-11-21 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases