A. Titan Instruments
Carver, Hollenbeck, Double Ended, Short, Ultra Light
5manufacturers in China registered for this device type
38catalogue 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 | A. Titan Instruments, Inc., 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 | 2023-01-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4-5 | In distribution | |
| Wall 1 22 | In distribution | |
| Hollenbeck 3 | In distribution | |
| Hollenbeck 1 | In distribution | |
| PKT-3 | In distribution | |
| Hol 3 22 | In distribution | |
| PKT-4 22 | In distribution | |
| Levy 7 | In distribution | |
| Hollenbeck 3S UL | In distribution | |
| PKT-5 22 | In distribution | |
| PKT-1 | In distribution | |
| PKT-5 | In distribution | |
| PKT-3 22 | In distribution | |
| Hollenbeck 3S | In distribution | |
| Tanner 5 22 | In distribution | |
| PKT-2 | In distribution | |
| Hol 3S 22 | In distribution | |
| 3-6 UL | In distribution | |
| PKT-1 22 | In distribution | |
| 3-6 22 | In distribution | |
| Ward 2 | In distribution | |
| 89-92 | In distribution | |
| SHO-A 22 | In distribution | |
| 89-92 22 | In distribution | |
| PKT-2 22 | In distribution | |
| 90-93 | In distribution | |
| Wall 3 | In distribution | |
| LL | In distribution | |
| Ward 1 22 | In distribution | |
| 5T | In distribution | |
| Tanner 5 | In distribution | |
| 90-93 UL | In distribution | |
| 89-92 UL | In distribution | |
| PKT-4 | In distribution | |
| Tanner 6 | In distribution | |
| 90-93 22 | In distribution | |
| Ward 2 22 | In distribution | |
| 3-6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 284 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 154 |
| American Eagle Instruments | American Eagle Instruments | 72 |
| Zoll-Dental | Zoll-Dental | 43 |
| Power Dental USA | Power Dental U.S.A. Inc. | 39 |
| 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.