Poly Siloxane Impression Material
by Clinician's Choice Dental Products, Inc.
510(k) K053014
Poly Siloxane Impression Material is a Class II device made by Clinician's Choice Dental Products, Inc., cleared under FDA 510(k) K053014 on 15 Nov 2005, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053014 | Date15 Nov 2005 | StatusActive |
Official records
- FDA 510(k) database K053014
Recalls
-
- Terminated Z-1100-2022
Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
Timeline
- Cleared FDA 510(k) K053014
- Recall initiated FDA recalls Z-1100-2022
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- Withdrawn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 K053014
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 | |||
|---|---|---|---|---|
| Affinity™ Heavy Body Fast Set w/o Tips 2-Pack 023405W | 023405W / 023405W | 00359883002091 | Total Volume 50 mL | On the market |
| Affinity™ Heavy Body FS 12-Pack 013952 | 013952 / 013952 | 00359883001636 | Total Volume 50 mL | On the market |
| Affinity™ Heavy Body FS 120ml Cartridge 013406 | 013406 / 013406 | 00359883001599 | Total Volume 120 mL | On the market |
| Affinity™ Heavy Body FS Cartridge 013405 | 013405 / 013405 | 00359883001582 | Total Volume 50 mL | On the market |
| Affinity™ Heavy Body FS Mega Mix 380mL 013386 | 013386 / 013386 | 00359883006006 | Total Volume 380 mL | On the market |
| Affinity™ Heavy Body Reg Set w/o Tips 2-Pack 023400W | 023400W / 023400W | 00359883002039 | Total Volume 50 mL | On the market |
| Affinity™ Heavy Body RS 12-Pack 013912 | 013912 / 013912 | 00359883001612 | Total Volume 50 mL | On the market |
| Affinity™ Heavy Body RS 120ml Cartridge 013401 | 013401 / 013401 | 00359883001575 | Total Volume 120 mL | On the market |
| Affinity™ Heavy Body RS Cartridge 013400 | 013400 / 013400 | 00359883001568 | Total Volume 50 mL | On the market |
| Affinity™ Heavy Body RS Mega Mix 380mL 013381 | 013381 / 013381 | 00359883005993 | Total Volume 380 mL | On the market |
| Affinity™ Inflex Fast Set w/o Tips 2-Pack 022405W | 022405W / 022405W | 00359883001971 | Total Volume 50 mL | On the market |
| Affinity™ Inflex FS 12-Pack 012952 | 012952 / 012952 | 00359883001551 | Total Volume 50 mL | On the market |
| Affinity™ Inflex FS 120ml Cartridge 012406 | 012406 / 012406 | 00359883001513 | Total Volume 120 mL | On the market |
| Affinity™ Inflex FS Mega Mix 380mL 012386 | 012386 / 012386 | 00359883005986 | Total Volume 380 mL | On the market |
| Affinity™ Inflex Reg Set w/o Tips 2-Pack 022400W | 022400W / 022400W | 00359883001919 | Total Volume 50 mL | On the market |
| Affinity™ Inflex RS 12-Pack 012912 | 012912 / 012912 | 00359883001537 | Total Volume 50 mL | On the market |
| Affinity™ Inflex RS 120ml Cartridge 012401 | 012401 / 012401 | 00359883001490 | Total Volume 120 mL | On the market |
| Affinity™ Inflex RS Affinity Cartridge 012400 | 012400 / 012400 | 00359883001483 | Total Volume 50 mL | On the market |
| Affinity™ Inflex RS Mega Mix 380mL 012381 | 012381 / 012381 | 00359883006525 | Total Volume 380 mL | On the market |
| Affinity™ Light Body HF FS Cartridge 014425 | 014425 / 014425 | 00359883001674 | Total Volume 50 mL | On the market |
| Affinity™ Light Body HF RS Cartridge 014420 | 014420 / 014420 | 00359883001667 | Total Volume 50 mL | On the market |
| Affinity™ Light Body High Flow Fast Set w/o Tips 2-Pack 024425W | 024425W / 024425W | 00359883002275 | Total Volume 50 mL | On the market |
| Affinity™ Light Body High Flow Reg Set w/o Tips 2-Pack 024420W | 024420W / 024420W | 00359883002237 | Total Volume 50 mL | On the market |
| Affinity™ Light Body Reg Flow Fast Set w/o Tips 2-Pack 024415W | 024415W / 024415W | 00359883002190 | Total Volume 50 mL | On the market |
| Affinity™ Light Body RF FS Cartridge 014415 | 014415 / 014415 | 00359883001650 | Total Volume 50 mL | On the market |
| Affinity™ Light Body RF RS Cartridge 014410 | 014410 / 014410 | 00359883001643 | Total Volume 50 mL | On the market |
| Affinity™ Light Body XL w/o Tips 2-Pack 024426W | 024426W / 024426W | 00359883002312 | Total Volume 50 mL | On the market |
| Affinity™ Monophase 12-Pack 019540 | 019540 / 019540 | 00359883001834 | Total Volume 50 mL | On the market |
| Affinity™ Monophase Cartridge 015400 | 015400 / 015400 | 00359883001704 | Total Volume 50 mL | On the market |
| Affinity™ Monophase w/o tips 2-Pack 025400W | 025400W / 025400W | 00359883002350 | Total Volume 50 mL | On the market |
| Affinity™ Putty 027200 | 027200 / 027200 | 00359883002404 | Total Volume 305 mL | On the market |
| Affnity™ Inflex FS Affinity Cartridge 012405 | 012405 / 012405 | 00359883001506 | Total Volume 50 mL | On the market |
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Other devices filed under FDA product code ELW (Material, Impression).
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