Gingi-Aid Gel
FDA 510(k) clearance K211419 · decided 2022-01-10
Clearance details
- K-number
- K211419
- Device name
- Gingi-Aid Gel
- Applicant
- Belport Company, Inc., Gingi-Pak
- Decision
- Substantially Equivalent
- Date received
- 2021-05-07
- Decision date
- 2022-01-10
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- MVL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Camarillo, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CyClean Cord (K254239) | SS GLOBAL | 2026-03-27 |
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| Retraxil (K243910) | Kulzer, LLC | 2025-09-24 |
| Stasis Gel (K211420) | Belport Company, Inc., Gingi-Pak | 2022-03-14 |
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| Vista Clear (K193389) | Inter-Med/Vista Dental Products | 2020-03-04 |
| Vista FS, Vista FS Liquid (K190220) | Inter-Med/Vista Dental Products | 2019-06-10 |
| Smartcord, Smartcord X (K171577) | Eastdent Co., Ltd. | 2018-05-03 |
| GingiDent Gingival Retraction Paste (K162662) | Pac-Dent International, Inc. | 2017-10-20 |
| Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials (K162948) | Kerr Corporation | 2017-08-08 |
| GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord (K162536) | Kerr Corporation | 2017-02-03 |
Recalls involving this device
No recalls on record reference this clearance.