510(k) K952353
- Device
- EZ-COMP
- Applicant
- ADM, INC.
- 510(k) number
- K952353
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-08-10
- Date received
- 1995-05-19
- Regulation
- 872.3690
- Classification name
- Material, Tooth Shade, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- ROBERT W BAUER
- Address
- 1819 S. May St., 2f Chicago IL US 60608 60608
FDA Registration Numbers
- 3002789526
- 3005176727
- 1410097
- 3013584861
- 3003114027
- 9612352
- 3006316962
- 3012312751
- 2916735
- 1281412
- 3039433962
- 3017674095
- 1420052
- 3015978392
- 3012389497
- 1420089
- 3031841433
- 3030515618
- 3019596325
- 9681356
- 2241860
- 2086043
- 3009117991
- 3007791519
- 3013557697
- 2433629
- 3005347791
- 9680954
- 3032378317
- 3009482106
- 3006694515
- 3012187973
- 8030452
- 8030067
- 1424442
- 3005665377
- 3012354669
- 8044038
- 3012441963
- 9613953
- 3003637274
- 3002807050
- 3003449480
- 3008912871
- 3000268902
- 3024749697
- 3032312561
- 3006291983
- 8030938
- 1215305
- 1937100
- 3015302693
- 3010131268
- 1221541
- 3004967419
- 3022296393
- 8010908
- 2511556
- 2027375
- 3012627824
- 1000118628
- 2424472
- 1718476
- 3003621174
- 3008582406
- 2024980
- 3038718579
- 9615399
- 3026400121
- 3027616
- 2411797
- 9681210
- 3024185724
- 3010419931
- 3007113445
- 1000272892
- 3010864832
- 3032027578
- 3026312357
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08595652700726 | Fibrafill® DENTIN Sample | ADM, a.s. | 2021-12-10 |
| 08595652700689 | Fibrafill® FLOW | ADM, a.s. | 2021-12-10 |
| 08595652700672 | Fibrafill® DENTIN | ADM, a.s. | 2021-12-10 |
| 08595652700733 | Fibrafill® FLOW Sample | ADM, a.s. | 2021-12-10 |
| 08595652700696 | Fibrafill® CUBE S Sample | ADM, a.s. | 2021-04-13 |
| 08595652700641 | Fibrafill® CUBE S | ADM, a.s. | 2021-04-13 |
| 08595652700252 | Dentapreg® PINPost small | ADM, a.s. | 2017-03-28 |
| 08595652700269 | Dentapreg® PINPost large | ADM, a.s. | 2017-03-28 |
| 08595652700528 | Dentapreg® MESH Pink 3 pcs. | ADM, a.s. | 2016-11-22 |
| 08595652700511 | Dentapreg® Veil | ADM, a.s. | 2016-11-22 |
| 08595652700504 | Dentapreg® Braid | ADM, a.s. | 2016-11-22 |
| 08595652700498 | Dentapreg® Bundle | ADM, a.s. | 2016-11-22 |
| 08595652700481 | Dentapreg® INTRO | ADM, a.s. | 2016-11-22 |
| 08595652700320 | Dentapreg® SFU Reinforcement | ADM, a.s. | 2016-11-22 |
| 08595652700313 | Dentapreg® UFM Crown | ADM, a.s. | 2016-11-22 |
| 08595652700306 | Dentapreg® PFU Posterior Bridge | ADM, a.s. | 2016-11-22 |
| 08595652700290 | Dentapreg® PFM Anterior Bridge | ADM, a.s. | 2016-11-22 |
| 08595652700283 | Dentapreg® SFM Splinting | ADM, a.s. | 2016-11-22 |
| 08595652700542 | Dentapreg® MESH Pink Single | ADM, a.s. | 2016-11-22 |
| 08595652700566 | Dentapreg® MESH Pink Economy Pack | ADM, a.s. | 2016-11-22 |
Other 510(k) Records For Product Code EBF
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | 2026-05-19 |
| K260805 | Dual Core | Vericom Co., Ltd. | 2026-05-11 |
| K261357 | Grandio disc multicolor | Voco GmbH | 2026-04-27 |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026-04-23 |
| K260661 | Midas Restore | Sprintray, Inc. | 2026-04-15 |
| K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2026-04-06 |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | 2026-03-11 |
| K254245 | ZAFIRA® | New Stetic, SA | 2026-03-03 |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-01-21 |
| K252465 | Any-Core | Mediclus Co., Ltd. | 2025-12-05 |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | 2025-11-07 |
| K253236 | G-BLOCK | Graphenano Dental S.L. | 2025-09-29 |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-09-23 |
| K251946 | G aenial Universal Injectable II | GC America, Inc. | 2025-08-29 |
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