510(k) K183436
- Device
- OraCure
- Applicant
- TBM Corporation
- 510(k) number
- K183436
- Product code
- OLR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-09-18
- Date received
- 2018-12-11
- Regulation
- 510(k) Premarket Notification
- Classification name
- Oral Wound Dressing
- 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
- Jae-woong Jeong
- Address
- B-301, Gwangju High-Tech Center, 313, Cheomadangwagi-Ro, Buk-Gu Gwangju KR 61008 61008
FDA Registration Numbers#
- 8043396
- 3016611551
- 3003311293
- 3019867040
- 3010143501
- 1450662
- 3007735241
- 2032542
- 3013576473
- 3010864832
- 3016505723
- 3016096134
- 2244725
- 3004050854
- 3011276993
- 3004985762
- 1424263
- 3004146122
- 3005488444
- 3006619672
- 3029906643
- 9611959
- 3015528146
- 2135339
- 3012263097
- 1646434
- 3006497550
- 2518467
- 3005488671
- 3004087544
- 2938386
Source Documents#
Other 510(k) Records For Product Code OLR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253816 | MuCover (proposed name) Oral Wound Dressing | MoleculeX Co., Ltd. | 2026-05-21 |
| K253758 | Dental Cone; Dental Sponge | Medizin Produkte Neustadt GmbH (Mpn) | 2025-12-18 |
| K252425 | Silatrix Oral Gel | Sa3, LLC | 2025-10-23 |
| K241283 | Elemental Granulate | Zinkh NV | 2025-01-03 |
| K230529 | HealiAid Dental Collagen Wound Dressing | Maxigen Biotech, Inc. | 2023-11-22 |
| K221428 | PerioStom Dental Dressing | Forward Science, LLC | 2022-12-22 |
| K211851 | Ora-Aid | Tbm Corporation | 2022-01-11 |
| K210211 | PuraStat-OM | 3-D Matrix, Inc. | 2021-10-08 |
| K203091 | MucoLock Oral Gel | Pcca, Inc. | 2021-02-12 |
| K202000 | Silatrix Oral Gel | Sa3, LLC | 2020-11-20 |
| K193336 | Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse | Synedgen, Inc. | 2020-05-27 |
| K191987 | Orapeutic | Forward Science | 2019-11-27 |
| K173196 | SUNTOUCH Dental Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2018-01-24 |
| K130959 | AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL | Bioplax Limited | 2014-04-04 |
| K112568 | AONGEN DENTAL COLLAGEN MATRIX | Aeon Astron Europe B.V. | 2012-03-01 |
Legacy Summary#
summary
FDA Review#
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