510(k) K852741
- Device
- DURA CONDITIONER
- Applicant
- RELIANCE DENTAL MFG. CO.
- 510(k) number
- K852741
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-09-23
- Date received
- 1985-06-27
- Regulation
- 872.3760
- Classification name
- Resin, Denture, Relining, Repairing, Rebasing
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- ROBERT J FAXEL
- Address
- 5805 W. 117th Pl. Worth IL US 60482 60482
FDA Registration Numbers
- 3008912871
- 9681199
- 3022545323
- 3032727
- 9680144
- 3005343849
- 3010368334
- 1000303432
- 9612300
- 2950685
- 2014676
- 3015532223
- 3005665377
- 3014888923
- 3008757014
- 1416675
- 1417322
- 3008569063
- 3013551048
- 3008910197
- 3012187973
- 1415367
- 3008347275
- 3004966444
- 3012623144
- 2954315
- 8044164
- 3021024355
- 3005344553
- 3004905070
- 3004935484
- 1038806
- 3005598536
- 3011649314
- 3007791519
- 4565
- 3015302693
- 9616065
- 3008578884
- 2023950
- 3025124
- 3024227208
- 3021381014
- 3004578725
- 3009496224
- 9610902
- 1483306
- 2916735
- 3013343038
- 3020841418
- 3005459236
- 3040605150
- 3016074824
- 3003310824
- 3004086252
- 1223843
- 9681210
- 3030515618
- 3012421607
- 1000118628
- 2087259
- 3011824442
- 3020093493
- 3009432160
- 3006542438
- 2523320
- 3039433962
- 8031054
- 3012389497
- 1410097
- 1043617
- 2424472
- 3006942327
- 3005904906
- 8021851
- 9681356
- 2280629
- 8030452
- 2921595
- 3013934196
- 3016237718
- 8010908
- 3004003391
- 3008254125
- 3008590411
- 3010002722
- 8010638
- 3008494285
- 1420052
- 9681531
- 3001389926
- 3003928050
- 3009426332
- 3005350578
- 1417846
- 3006694515
- 3003621174
- 3012494290
- 3003103749
- 1000243214
- 2024312
- 9612352
- 3010664129
- 3003756493
- 3023346365
- 3027616
- 2032112
- 3008320092
- 8010711
- 3014289665
- 2411797
- 3009727738
- 2436918
- 3013425656
- 3015674635
- 2183301
- 3038718579
- 1316408
- 9710611
- 2133714
- 3012441963
- 2435952
- 3030686055
- 9680954
- 1000625496
- 3017183443
- 3022068322
- 3026312357
- 1000486347
- 3002807050
- 9613953
- 1221541
- 3003794907
- 3007126709
- 3027303702
- 2433919
- 3017450159
- 3004130302
- 3003231822
- 3017374693
- 2244842
- 3006697692
- 3014270094
- 9680348
- 3011203516
- 3024749697
- 8010019
- 3011532731
- 3027526455
- 3009482106
- 3039359767
- 3009440973
- 3002789526
- 3011511773
- 2242866
- 2086043
- 3014778017
- 3027494823
- 3009312537
- 3010564008
- 2515379
- 3033085428
- 2032807
- 2081055
- 1000277456
- 8030870
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D9471805P1 | Dura Conditioner Bulk Package - Pink | Reliance Dental Manufacturing Co Inc | 2022-08-23 |
| D9471805 | Dura Conditioner Bulk Package - White | Reliance Dental Manufacturing Co Inc | 2022-08-23 |
| D9471801P1 | Dura Conditioner Complete Package - Pink | Reliance Dental Manufacturing Co Inc | 2022-08-23 |
| D9471801 | Dura Conditioner Complete Package - White | Reliance Dental Manufacturing Co Inc | 2022-08-23 |
| D9471706C1 | Dura Rely-A-Soft Economy Package - Clear | Reliance Dental Manufacturing Co Inc | 2022-08-23 |
| D9471706 | Dura Rely-A-Soft Economy Package - Pink | Reliance Dental Manufacturing Co Inc | 2022-08-23 |
| D9471701C1 | Dura Rely-A-Soft Complete Package - Clear | Reliance Dental Manufacturing Co Inc | 2022-08-23 |
| D9471701 | Dura Rely-A-Soft Complete Package - Pink | Reliance Dental Manufacturing Co Inc | 2022-08-23 |
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 |
| 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 |
| 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 |
| K243336 | Lucitone Digital Print Denture System | Dentsply Sirona, Inc. | 2024-12-17 |
| K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024-11-22 |
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