Precision Vps Impression Material
510(k) K040053
Precision Vps Impression Material is a medical device (FDA Class II; FDA product code ELW, Material, Impression) made by Discus Dental, Inc., cleared under FDA 510(k) K040053 on 25 Mar 2004, 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 | FDA 510(k)SESE | NumberK040053 | Date25 Mar 2004 | StatusActive |
Official records
- FDA 510(k) database K040053
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELW
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K040053
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 | |||
|---|---|---|---|---|
| Henry Schein 5702965 | 5702965 / 5702965 | 00304040144022 | On the market | |
| Henry Schein 5702966 | 5702966 / 5702966 | 00304040144039 | On the market | |
| Henry Schein 5702969 | 5702969 / 5702969 | 00304040162873 | On the market | |
| Henry Schein 5702970 | 5702970 / 5702970 | 00304040162880 | On the market | |
| Henry Schein 5702972 | 5702972 / 5702972 | 00304040162903 | On the market | |
| Henry Schein 5702973 | 5702973 / 5702973 | 00304040162910 | On the market | |
| Henry Schein 5702974 | 5702974 / 5702974 | 00304040162927 | On the market | |
| Henry Schein 5702976 | 5702976 / 5702976 | 00304040162941 | On the market | |
| Henry Schein 5702977 | 5702977 / 5702977 | 00304040162866 | On the market | |
| Henry Schein 5702989 | 5702989 / 5702989 | 00304040162965 | On the market | |
| Henry Schein 5702990 | 5702990 / 5702990 | 00304040162972 | On the market | |
| Henry Schein 5702991 | 5702991 / 5702991 | 00304040162989 | On the market | |
| Henry Schein 5702993 | 5702993 / 5702993 | 00304040163009 | On the market | |
| Henry Schein 5702994 | 5702994 / 5702994 | 00304040163016 | On the market | |
| Henry Schein 5702997 | 5702997 / 5702997 | 00304040163047 | On the market | |
| Henry Schein 5703001 | 5703001 / 5703001 | 00304040159590 | On the market | |
| Henry Schein 5703005 | 5703005 / 5703005 | 00304040162828 | On the market | |
| Henry Schein 5703008 | 5703008 / 5703008 | 00304040163054 | On the market | |
| Henry Schein 5703009 | 5703009 / 5703009 | 00304040163061 | On the market | |
| Henry Schein 5703013 | 5703013 / 5703013 | 00304040163108 | On the market | |
| Henry Schein 5703014 | 5703014 / 5703014 | 00304040163115 | On the market | |
| Henry Schein 5703015 | 5703015 / 5703015 | 00304040163122 | On the market | |
| Henry Schein 5703016 | 5703016 / 5703016 | 00304040163139 | On the market | |
| Henry Schein 5703025 | 5703025 / 5703025 | 00304040163221 | On the market | |
| Henry Schein 5703028 | 5703028 / 5703028 | 00304040163252 | On the market | |
| Henry Schein 5703029 | 5703029 / 5703029 | 00304040163269 | On the market | |
| Henry Schein 5703030 | 5703030 / 5703030 | 00304040163276 | On the market | |
| Henry Schein 5703032 | 5703032 / 5703032 | 00304040163290 | On the market | |
| Henry Schein 5703033 | 5703033 / 5703033 | 00304040163306 | On the market | |
| Henry Schein 5703035 | 5703035 / 5703035 | 00304040163320 | On the market | |
| Henry Schein 5703037 | 5703037 / 5703037 | 00304040163344 | On the market | |
| Henry Schein 5703040 | 5703040 / 5703040 | 00304040163375 | On the market | |
| Henry Schein 5703041 | 5703041 / 5703041 | 00304040163382 | On the market | |
| Henry Schein 5703042 | 5703042 / 5703042 | 00304040163399 | On the market | |
| Henry Schein 5703043 | 5703043 / 5703043 | 00304040163405 | On the market | |
| Henry Schein 5703045 | 5703045 / 5703045 | 00304040163429 | On the market | |
| Henry Schein 5703046 | 5703046 / 5703046 | 00304040163436 | On the market | |
| Henry Schein 5703047 | 5703047 / 5703047 | 00304040163443 | On the market | |
| Henry Schein 5703048 | 5703048 / 5703048 | 00304040163450 | On the market | |
| Henry Schein 5703051 | 5703051 / 5703051 | 00304040163481 | On the market | |
| Henry Schein 5703052 | 5703052 / 5703052 | 00304040163498 | On the market | |
| Precision® SPD1509 | SPD1509 / SPD1509 | D813SPD15090 | On the market | |
| Precision® SPD1510 | SPD1510 / SPD1510 | D813SPD15100 | On the market | |
| Precision® SPD1511 | SPD1511 / SPD1511 | D813SPD15110 | On the market | |
| Precision® SPD1514 | SPD1514 / SPD1514 | D813SPD15141 | On the market | |
| Precision® SPD1517 | SPD1517 / SPD1517 | D813SPD15170 | On the market | |
| Precision® SPD1533 | SPD1533 / SPD1533 | D813SPD15330 | On the market | |
| Precision® SPD1534 | SPD1534 / SPD1534 | D813SPD15340 | On the market | |
| Precision® SPD1536 | SPD1536 / SPD1536 | D813SPD15360 | On the market | |
| Precision® SPD1547 | SPD1547 / SPD1547 | D813SPD15470 | On the market |
Similar devices
Other devices filed under FDA product code ELW (Material, Impression).
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- ALGINATE IMPRESSION MATERIAL by Rite-Dent Manufacturing Corp.
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- 1ST IMPRESSION by WYKLE RESEARCH, INC.
- AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL by Dentsply Intl.
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