Locator, Compatible With AstraTech Implant System
LOCATOR "Extra Light Retention" Extended Range Replacement Male (Red) (4 Pack)
6manufacturers in China registered for this device type
8catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Hong Kong (2), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Qibei Technology Co., Limited | Kl | Hong Kong | Manufacturer | 15 |
| Hubei YJT Intelligent Technology Group Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 12 |
| Crown Trading (HK) Co., Limited | Hong Kong | Hong Kong | Manufacturer | 8 |
| Vivi Dental Laboratory | Shenzhen | Guangdong | Manufacturer | 8 |
| Shanghai Shift Electrics Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 7 |
Record
| Listed by | Zest Anchors, LLC, United States |
|---|---|
| FDA product code | EGG |
| Device type | Attachment, Precision, All |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3165 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-07-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08915 | In distribution | |
| 08519-2 | In distribution | |
| 08548 | In distribution | |
| 08547 | In distribution | |
| 08558 | In distribution | |
| 08529 | In distribution | |
| 08527 | In distribution | |
| 08524 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ceka & Preci-Line Attachments | Alphadent Co., Ltd. | 300 |
| Dental Attachments | Rhein 83 SRL | 202 |
| Preat | Preat Corporation | 192 |
| SI | Shinhung MST Co., Ltd. | 140 |
| Dental Equipments | Rhein 83 SRL | 83 |
| OT Equator – OT Bridge | Rhein 83 SRL | 82 |
| evertis | Shinhung MST Co., Ltd. | 71 |
| StecoTitanmagnetics® | Steco-System-Technik Gmbh & Co. KG | 70 |
| Implant Prosthetics | Preat Corporation | 70 |
| ‘MagnaCap’ Magnetic Retention System | Technovent Limited | 61 |
| Zaag | Zest Anchors, LLC | 48 |
| Locator® | Zest Anchors, LLC | 47 |
Showing 12 of 333. All products under Attachment, Precision, All
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K925700 | 1994-04-07 |
| K882063 | 1988-06-13 |
| K861561 | 1986-05-21 |
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.