510(k) K091380
- Device
- CORDCAP
- Applicant
- CENTRIX, INC.
- 510(k) number
- K091380
- Product code
- MVL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-07-30
- Date received
- 2009-05-11
- Regulation
- 510(k) Premarket Notification
- Classification name
- Cord, Retraction
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Dental
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN DISCKO
- Address
- 770 River Rd. Shelton CT US 06484 06484
FDA Registration Numbers#
- 3013584861
- 2513595
- 9616142
- 3008912871
- 9610964
- 8020994
- 3012058545
- 1941138
- 1281412
- 2014676
- 9611385
- 2243757
- 3007743883
- 8010908
- 8010629
- 2511556
- 2431069
- 3011632
- 9680845
- 3003677417
- 3038718579
- 3013298431
- 9610902
- 2411797
- 3007113445
- 1000272892
- 2018957
- 2183301
- 3006694515
- 3012187973
- 2133714
- 2515379
- 3012494290
- 3035693034
- 3012421607
- 1718912
- 2024312
- 3005665377
- 3043226252
- 3011689956
Source Documents#
Other 510(k) Records For Product Code MVL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254239 | CyClean Cord | SS GLOBAL | 2026-03-27 |
| K253797 | One-Stop | Mediclus Co., Ltd. | 2026-02-27 |
| K243910 | Retraxil | Kulzer, LLC | 2025-09-24 |
| K211420 | Stasis Gel | Belport Company, Inc., Gingi-Pak | 2022-03-14 |
| K211419 | Gingi-Aid Gel | Belport Company, Inc., Gingi-Pak | 2022-01-10 |
| K213149 | VOCO Retraction Paste | Voco GmbH | 2021-12-09 |
| K200764 | STATSTIX | Centrix Incorporated | 2020-10-15 |
| K193389 | Vista Clear | Inter-Med/Vista Dental Products | 2020-03-04 |
| K190220 | Vista FS, Vista FS Liquid | Inter-Med/Vista Dental Products | 2019-06-10 |
| K171577 | Smartcord, Smartcord X | Eastdent Co., Ltd. | 2018-05-03 |
| K162662 | GingiDent Gingival Retraction Paste | Pac-Dent International, Inc. | 2017-10-20 |
| K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials | Kerr Corporation | 2017-08-08 |
| K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord | Kerr Corporation | 2017-02-03 |
| K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord | Kerr Corporation | 2017-01-13 |
| K152064 | Astringedent Clear | Ultradent Products, Inc. | 2015-09-24 |
Legacy Summary#
summary
FDA Review#
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