510(k) K896719
- Device
- PRIMER-P ADHESIVE AGENT
- Applicant
- PARKELL
- 510(k) number
- K896719
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-22
- Date received
- 1989-11-29
- 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
Applicant Contact#
- Contact
- J GENDUSA,DDS
- Address
- 155 Schmitt Blvd. P.O. Box 376 Farmingdale NY US 11735 11735
FDA Registration Numbers#
- 2087259
- 3011824442
- 1000118628
- 3021381014
- 1000277456
- 3004905070
- 3004935484
- 3014270094
- 1000303432
- 2032807
- 3008494285
- 3003621174
- 3015491441
- 3039433962
- 3006697692
- 2280629
- 3015674635
- 2433919
- 3013425656
- 3044819802
- 8010908
- 3023346365
- 3008569063
- 1416675
- 3005598536
- 8021851
- 3021024355
- 3030515618
- 9710611
- 9681210
- 3004966444
- 2081055
- 3005350578
- 3007126709
- 3011203516
- 3017374693
- 3008320092
- 3003231822
- 3007791519
- 3027616
- 8030452
- 3003310824
- 3024749697
- 3027494823
- 4565
- 3012187973
- 8030870
- 3039359767
- 2515379
- 1038806
- 3030686055
- 2530024
- 2242866
- 3020841418
- 3006942327
- 3005343849
- 2950685
- 3008254125
- 3010002722
- 3015532223
- 1221541
- 3009482106
- 3012421607
- 3006542438
- 3002807050
- 3032727
- 2523320
- 3009426332
- 3022068322
- 3015302693
- 9616065
- 1316408
- 3008590411
- 9680348
- 3043226252
- 3004086252
- 3040605150
- 3003103749
- 2024312
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#
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