The following data is part of a premarket notification filed by Creodent Prosthetics, Ltd. with the FDA for Creodent Solidex Custom Abutment.
| Device ID | K160436 |
| 510k Number | K160436 |
| Device Name: | CreoDent Solidex Custom Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, NY 10001 |
| Contact | Calvin Shim |
| Correspondent | Calvin Shim CreoDent Prosthetics Ltd. 29 West 30th Street, 11th Floor New York, NY 10001 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-17 |
| Decision Date | 2016-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D124PMRBL0 | K160436 | 000 |
| D124AS40AS100 | K160436 | 000 |
| D124AS40AS50 | K160436 | 000 |
| D124AS40S100 | K160436 | 000 |
| D124AS40S50 | K160436 | 000 |
| D124AS50AS100 | K160436 | 000 |
| D124AS50AS50 | K160436 | 000 |
| D124AS50S100 | K160436 | 000 |
| D124AS50S50 | K160436 | 000 |
| D124OTMAS100 | K160436 | 000 |
| D124OTMAS50 | K160436 | 000 |
| D124OTMS100 | K160436 | 000 |
| D124OTMS50 | K160436 | 000 |
| D124OTRAS100 | K160436 | 000 |
| D124AS30S50 | K160436 | 000 |
| D124AS30S100 | K160436 | 000 |
| D124AS30AS50 | K160436 | 000 |
| D124OTM0 | K160436 | 000 |
| D124OTM60 | K160436 | 000 |
| D124OTMAS0 | K160436 | 000 |
| D124OTMB140 | K160436 | 000 |
| D124OTMBL0 | K160436 | 000 |
| D124OTMNE0 | K160436 | 000 |
| D124OTMS0 | K160436 | 000 |
| D124OTR0 | K160436 | 000 |
| D124OTR60 | K160436 | 000 |
| D124OTRAS0 | K160436 | 000 |
| D124OTRB140 | K160436 | 000 |
| D124OTRBL0 | K160436 | 000 |
| D124AS30AS100 | K160436 | 000 |
| D124OTRAS50 | K160436 | 000 |
| D124OTRS10 | K160436 | 000 |
| D124OTRS50 | K160436 | 000 |
| D124AS400 | K160436 | 000 |
| D124AS4060 | K160436 | 000 |
| D124AS40AS0 | K160436 | 000 |
| D124AS40B140 | K160436 | 000 |
| D124AS40BL0 | K160436 | 000 |
| D124AS40NE0 | K160436 | 000 |
| D124AS40S0 | K160436 | 000 |
| D124AS500 | K160436 | 000 |
| D124AS5060 | K160436 | 000 |
| D124AS50AS0 | K160436 | 000 |
| D124AS50B140 | K160436 | 000 |
| D124AS50BL0 | K160436 | 000 |
| D124AS50NE0 | K160436 | 000 |
| D124AS30S0 | K160436 | 000 |
| D124AS30NE0 | K160436 | 000 |
| D124AS30BL0 | K160436 | 000 |
| D124OTMMAS0 | K160436 | 000 |
| D124OTRMAS0 | K160436 | 000 |
| D124OTRNE0 | K160436 | 000 |
| D124OTRS0 | K160436 | 000 |
| D124AS30SCA0 | K160436 | 000 |
| D124AS40SCA0 | K160436 | 000 |
| D124AS50SCA0 | K160436 | 000 |
| D124OTMSCA0 | K160436 | 000 |
| D124OTRSCA0 | K160436 | 000 |
| D124AS300 | K160436 | 000 |
| D124AS3060 | K160436 | 000 |
| D124AS30AS0 | K160436 | 000 |
| D124AS30B140 | K160436 | 000 |
| D124AS50S0 | K160436 | 000 |