American Eagle Instruments
M5 Restorative Series M5-Anterior
5manufacturers in China registered for this device type
72catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
Record
| Listed by | American Eagle Instruments, United States |
|---|---|
| FDA product code | EKH |
| Device type | Carver, Dental Amalgam, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-23 |
| Record revised | 2024-04-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2024-04-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AECAIPCTTN | In distribution | |
| AECAIPCP | In distribution | |
| AECAUTSA37 | In distribution | |
| AECAG4-5TNZ | In distribution | |
| AECAC1 | In distribution | |
| NYUCAWO2/3 | In distribution | |
| AECA8ALTNZ | In distribution | |
| AECAG4-5 | In distribution | |
| AECAH2 | In distribution | |
| AECAW3 | In distribution | |
| AECA8ATN | In distribution | |
| AECADC89-92 | In distribution | |
| AECAIPC | In distribution | |
| AECA12L | In distribution | |
| AECAWO1 | In distribution | |
| AECADC1-2 | In distribution | |
| M5-ANTER | In distribution | |
| AECA11 | In distribution | |
| AECAUTRR | In distribution | |
| AECADC90B | In distribution | |
| AECARC | In distribution | |
| AEMT28 | In distribution | |
| AECAUTHSCSAPFI1-2 | In distribution | |
| AECADCUW-D5 | In distribution | |
| AEAF34-35 | In distribution | |
| AEMT26 | In distribution | |
| AEC8-9B | In distribution | |
| AECAWA2 | In distribution | |
| AECAIPC1M | In distribution | |
| AEMT29 | In distribution | |
| AEMT29-29C | In distribution | |
| AERECRZ | In distribution | |
| AECAIPCTTNZ | In distribution | |
| AECAH1 | In distribution | |
| AEMT27 | In distribution | |
| AECAG4-5TN | In distribution | |
| AEC1M | In distribution | |
| AEAF32-33 | In distribution | |
| AECA8A | In distribution | |
| AECAUTHSCSAPFIDO | In distribution | |
| AEMCCAIPCTNZ | In distribution | |
| AEEMG1CA | In distribution | |
| AECAH1/23 | In distribution | |
| AECAWA1/21 | In distribution | |
| AEEGP2S | In distribution | |
| AECI5644 | In distribution | |
| AECAF | In distribution | |
| AECAHATCH | In distribution | |
| AECADC5T | In distribution | |
| AECA76-7C | In distribution | |
| AECA8ATNZ | In distribution | |
| AECAIPC2M | In distribution | |
| AECAIPCLTN | In distribution | |
| AECADCW4 | In distribution | |
| AECAWA1 | In distribution | |
| AERECLZ | In distribution | |
| AECAIPCLTNZ | In distribution | |
| AECAH1/23Z | In distribution | |
| AEMT28-28C | In distribution | |
| AECADC3-6 | In distribution | |
| AECAH3 | In distribution | |
| AECADC4-5 | In distribution | |
| AECAT3 | In distribution | |
| AECA8ALTN | In distribution | |
| AEC3-4W | In distribution | |
| AEC5-6W | In distribution | |
| AECAIPCB | In distribution | |
| AECAIPCA | In distribution | |
| AECI4296 | In distribution | |
| AECAWO2 | Withdrawn | |
| AEC11-12B | Withdrawn | |
| AECAWO3 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 284 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 154 |
| Zoll-Dental | Zoll-Dental | 43 |
| Power Dental USA | Power Dental U.S.A. Inc. | 39 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 38 |
| Sklar® | Sklar Corporation | 33 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 29 |
| Reicodent | Devemed Gmbh | 29 |
| Premier Carvers | Premier Dental Products Co. | 20 |
| J & J Instruments Inc | J & J Instruments, LLC | 20 |
| devemed | Devemed Gmbh | 16 |
| PDT, Inc. | PDT, Inc. | 16 |
Showing 12 of 41. All products under Carver, Dental Amalgam, Operative
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.