LW Retraction Cap
510(k) K231079
LW Retraction Cap is a Class II device made by Ossvis Co., Ltd., cleared under FDA 510(k) K231079 on 14 Sep 2023 and listed in FDA GUDID since 20 Dec 2023 (UDI-DI 08809918230736), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number08809918230736 | Date20 Dec 2023 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | NumberK231079 | Date14 Sep 2023 | StatusActive |
Official records
- AccessGUDID record 08809918230736
- FDA 510(k) database K231079
Across registries
- FDA 510(k) K231079 decided 14 Sep 2023 Active
- FDA GUDID UDI-DI 08809918230736 listed 20 Dec 2023 Listed
Timeline
- Cleared FDA 510(k) K231079
- Listed FDA GUDID 08809918230736
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dental implant suprastructure, temporary, preformed, single-use
- Model / reference
- LWRC455
- Primary DI / UDI-DI
- 08809918230736
- 510(k) Number
- FDA product code
- NHA
- GMDN term
- Dental implant suprastructure, temporary, preformed, single-use
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Devices cleared under K231079
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| LW Solid Abutment SET LWSA4015FRS | LWSA4015FRS | 08809918234093 | — | On the market |
| LW Solid Abutment SET LWSA4027RS | LWSA4027RS | 08809918230989 | — | On the market |
| LW Solid Abutment SET LWSA4034RS | LWSA4034RS | 08809918230996 | — | On the market |
| LW Solid Abutment SET LWSA4035RS | LWSA4035RS | 08809918231009 | — | On the market |
| LW Solid Abutment SET LWSA4514FRS | LWSA4514FRS | 08809918234239 | — | On the market |
| LW Solid Abutment SET LWSA4515RS | LWSA4515RS | 08809918231092 | — | On the market |
| LW Solid Abutment SET LWSA4545RS | LWSA4545RS | 08809918231184 | — | On the market |
| LW Solid Abutment SET LWSA4554FRS | LWSA4554FRS | 08809918234352 | — | On the market |
| LW Solid Abutment SET LWSA5034RS | LWSA5034RS | 08809918231290 | — | On the market |
| LW Solid Abutment SET LWSA5524RS | LWSA5524RS | 08809918231412 | — | On the market |
| LW Solid Abutment SET LWSA5544RS | LWSA5544RS | 08809918231474 | — | On the market |
| LW Solid Abutment SET LWSA6024RS | LWSA6024RS | 08809918231566 | — | On the market |
| LW Solid Abutment SET LWSA6034RS | LWSA6034RS | 08809918231597 | — | On the market |
| LW Solid Abutment SET LWSA6514RS | LWSA6514RS | 08809918231689 | — | On the market |
| LW Solid Abutment SET LWSA6517FRS | LWSA6517FRS | 08809918234857 | — | On the market |
| LW Solid Abutment SET LWSA6524FRS | LWSA6524FRS | 08809918234864 | — | On the market |
| LW Solid Abutment SET LWSA7024FRS | LWSA7024FRS | 08809918235014 | — | On the market |
| LW Solid Abutment SET LWSA7044FRS | LWSA7044FRS | 08809918235076 | — | On the market |
| LW Solid Abutment SET LWSA7045FRS | LWSA7045FRS | 08809918235083 | — | On the market |
| LW Solid Abutment SET LWSA7054FRS | LWSA7054FRS | 08809918235106 | — | On the market |
| LW Vis Abutment SET LWCA4514FHRS | LWCA4514FHRS | 08809918243538 | — | On the market |
| LW Vis Abutment SET LWCA4524HRS | LWCA4524HRS | 08809918237261 | — | On the market |
| LW Vis Abutment SET LWCA4537NRS | LWCA4537NRS | 08809918238367 | — | On the market |
| LW Vis Abutment SET LWCA4545FNRS | LWCA4545FNRS | 08809918244689 | — | On the market |
| LW Vis Abutment SET LWCA4554HRS | LWCA4554HRS | 08809918237353 | — | On the market |
| LW Vis Abutment SET LWCA4565NRS | LWCA4565NRS | 08809918238442 | — | On the market |
| LW Vis Abutment SET LWCA4614NRS | LWCA4614NRS | 08809918238497 | — | On the market |
| LW Vis Abutment SET LWCA4625HRS | LWCA4625HRS | 08809918237483 | — | On the market |
| LW Vis Abutment SET LWCA4637FHRS | LWCA4637FHRS | 08809918243828 | — | On the market |
| LW Vis Abutment SET LWCA4647FNRS | LWCA4647FNRS | 08809918244900 | — | On the market |
| LW Vis Abutment SET LWCA4657FNRS | LWCA4657FNRS | 08809918244931 | — | On the market |
| LW Vis Abutment SET LWCA4657NRS | LWCA4657NRS | 08809918238633 | — | On the market |
| LW Vis Abutment SET LWCA4674NRS | LWCA4674NRS | 08809918238671 | — | On the market |
| LW Vis Abutment SET LWCA4675FHRS | LWCA4675FHRS | 08809918243934 | — | On the market |
| LW Vis Abutment SET LWCA5027HRS | LWCA5027HRS | 08809918237704 | — | On the market |
| LW Vis Abutment SET LWCA5044HRS | LWCA5044HRS | 08809918237742 | — | On the market |
| LW Vis Abutment SET LWCA5047NRS | LWCA5047NRS | 08809918238817 | — | On the market |
| LW Vis Abutment SET LWCA5054FHRS | LWCA5054FHRS | 08809918244078 | — | On the market |
| LW Vis Abutment SET LWCA5064HRS | LWCA5064HRS | 08809918237803 | — | On the market |
| LW Vis Abutment SET LWCA6015HRS | LWCA6015HRS | 08809918237872 | — | On the market |
| LW Vis Abutment SET LWCA6017HRS | LWCA6017HRS | 08809918237889 | — | On the market |
| LW Vis Abutment SET LWCA6025HRS | LWCA6025HRS | 08809918237902 | — | On the market |
| LW Vis Abutment SET LWCA6027FNRS | LWCA6027FNRS | 08809918245266 | — | On the market |
| LW Vis Abutment SET LWCA6057NRS | LWCA6057NRS | 08809918239050 | — | On the market |
| LW Vis Abutment SET LWCA6067FHRS | LWCA6067FHRS | 08809918244337 | — | On the market |
| LW Vis Abutment SET LWCA6067NRS | LWCA6067NRS | 08809918239081 | — | On the market |
| LW Vis Abutment SET LWCA6075FHRS | LWCA6075FHRS | 08809918244351 | — | On the market |
| LW Vis Abutment SET LWCA7014HRS | LWCA7014HRS | 08809918238077 | — | On the market |
| LW Vis Abutment SET LWCA7024NRS | LWCA7024NRS | 08809918239159 | — | On the market |
| LW Vis Abutment SET LWCA7054HRS | LWCA7054HRS | 08809918238190 | — | On the market |
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