Separable Fastener Assembly 10PK – Drill Kit Included
5 catalogue numbers from SFA10PKDK, listed by Smart Denture Conversions, LLC, United States, under Anchor, Preformed. 1 manufacturer in China is registered for this product code.
1manufacturer
5catalogue numbers in this listing
Who Else Makes It
Registered in Hunan.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
Record
| Listed by | Smart Denture Conversions, LLC, United States |
|---|---|
| FDA product code | EJX |
| Device type | Anchor, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3130 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-26 |
| Record revised | 2025-06-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SFA10PKDK | In distribution | |
| KDIH-SFA10PKDK | In distribution | |
| KDTL-SFA10PKDK | In distribution | |
| ZVLP-SFA10PKDK | In distribution | |
| ZVTS-SFA10PKDK | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OT Equator | Rhein 83 SRL | 26 |
| Dalbo®-PLUS | Cendres+Métaux SA | 18 |
| Keystone Industries | Keystone Industries | 14 |
| CM LOC® | Cendres+Métaux SA | 13 |
| OT Equator-Easy FIX | Rhein 83 SRL | 6 |
| Dalbo®-Z | Cendres+Métaux SA | 4 |
| Gerber RZ | Cendres+Métaux SA | 3 |
| Smileloc® BY Rodo | Rodo Medical, Inc | 3 |
| Dalbo®-B | Cendres+Métaux SA | 2 |
| Leixir Recharge Kit, Unigrip | Smart Denture Conversions, LLC | 1 |
| Tall Spare Parts Kit, Omnibut | Smart Denture Conversions, LLC | 1 |
| Tall TiBase 10PK, Omnibut | Smart Denture Conversions, LLC | 1 |
Showing 12 of 79. All products under Anchor, Preformed
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.