510(k) K882690
- Device
- IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL
- Applicant
- 3M COMPANY
- 510(k) number
- K882690
- Product code
- ELW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-08-11
- Date received
- 1988-06-30
- Regulation
- 872.3660
- Classification name
- Material, Impression
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DON H MCKENZIE
- Address
- Chemolite Blvd. & Washington City Rd. 19 Cottae Grove MN US 55016 55016
FDA Registration Numbers#
- 3008922120
- 3011187729
- 1410097
- 3005176727
- 3011203516
- 3006316962
- 3012312751
- 1281412
- 4565
- 3007353764
- 3007743883
- 2431069
- 3031841433
- 3005172141
- 3008648418
- 9681356
- 3003103749
- 2086043
- 9680954
- 3011050570
- 3006694515
- 3012187973
- 3013020540
- 2081322
- 3005665377
- 3012354669
- 3008895253
- 3015143007
- 3005558160
- 9613953
- 8021851
- 3003449480
- 3002807050
- 3008912871
- 3032312561
- 3004884150
- 3032911850
- 3010131268
- 2024949
- 8010908
- 3003775534
- 1718476
- 3008582406
- 3031886796
- 3017575849
- 3015332784
- 3038718579
- 3026400121
- 1836392
- 2024980
- 2411797
- 9681210
- 3010419931
- 3006191485
- 3010864832
- 2244812
- 3008966075
- 1721647
- 3011500388
- 2515379
- 3008792854
- 9614794
- 3013012934
- 3025307990
- 3043226252
- 3032193293
- 2087259
- 8020994
- 1032227
- 3005628474
- 3004425647
- 9612300
- 8021038
- 9614977
- 3027494823
- 9614573
- 3020749939
- 9611458
- 1413475
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ELW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254112 | Dia-X Sil Bite | DiaDent Group International | 2026-03-19 |
| K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); | Vigodent Indústria E Comercio Ltda | 2025-10-31 |
| K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4you AG | 2025-06-27 |
| K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. | 2024-12-27 |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator | Dent4you AG | 2024-11-15 |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&E Korea Co., Ltd. | 2024-02-13 |
| K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. | 2023-04-27 |
| K213175 | No Stress Impress | No Stress Impress, LLC | 2023-01-19 |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty | Genoss Co., Ltd. | 2022-12-15 |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | Hdi, Inc. | 2022-11-07 |
| K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) | Prevest Denpro Limited | 2022-09-09 |
| K221668 | Dental Impression Material | Chemoment Materials Co.,Ltd | 2022-08-08 |
| K213890 | IMICRYL Impression Materials | Imicryl Dis Malzemeleri San. VE Tic. A.S. | 2022-02-11 |
| K220257 | Permadyne | 3M Deutschland GmbH | 2022-02-01 |
| K220097 | PRESIDENT The Original | Coltène/Whaledent AG | 2022-01-13 |
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