Nordent Manufacturing, Inc.
Carver, DE, Large Cleoid Discoid #3 (3-6), DuraLite® ColorRing™ Handle
4manufacturers in China registered for this device type
34catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Guangdong (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 |
| Elite Dental LAB | Huizhou | Guangdong | Manufacturer | 18 |
Record
| Listed by | Nordent Manufacturing Inc |
|---|---|
| FDA product code | EIK |
| Device type | Carver, Wax, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2026-01-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Storage | Handling environment humidity 40 to 60 % RH; Handling environment temperature 0 to 350 °F; Storage environment temperature 65 to 75 °F |
| Sizes | Length 6.5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CECACD3 | Length 6.5 in | In distribution |
| CLPKT2 | In distribution | |
| CLVE | In distribution | |
| CLPKT1 | In distribution | |
| CLLC | In distribution | |
| *CL | In distribution | |
| CLPKT3T | In distribution | |
| CECAT5 | Length 6.5 in | In distribution |
| CECLPKT2 | In distribution | |
| CLHY | In distribution | |
| CLZA | In distribution | |
| CLRE | In distribution | |
| CLUABC1 | In distribution | |
| RECLPKT5 | In distribution | |
| CLPKT4 | In distribution | |
| RECLPKT4 | In distribution | |
| RECLPKT3 | In distribution | |
| RECLPKT1 | In distribution | |
| CECLPKT4 | In distribution | |
| CECLPKT1 | In distribution | |
| CECLPKT3 | In distribution | |
| CLRO | In distribution | |
| CLPKT5 | In distribution | |
| CLUABC2 | In distribution | |
| CECLPKT5 | In distribution | |
| RCAWA1S | Length 6.5 in | In distribution |
| CECAN138 | Length 6.5 in | In distribution |
| RECAURA2 | Length 6.5 in | In distribution |
| CLPKT3 | In distribution | |
| CECLPKT2 | Length 6.5 in | In distribution |
| RECLPKT2 | In distribution | |
| RECAURI1 | Length 6.5 in | In distribution |
| CECAWA1S | Length 6.5 in | In distribution |
| CL* | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 120 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 22 |
| J & J Instruments | J & J Instruments, LLC | 21 |
| Pomee | Pomee Corporation | 16 |
| Henry Schein | Henry Schein, Inc. | 16 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 13 |
| TBS Basics | Acme Enterprise. | 12 |
| Osung MND | Osung MND Co., Ltd. | 12 |
| Buffalo Dental Mfg | Buffalo Dental Manufacturing Co., Inc. | 9 |
| Zoll-Dental | Zoll-Dental | 9 |
| Premier Lab Instruments | Premier Dental Products Co. | 5 |
| PDT, Inc. | PDT, Inc. | 5 |
Showing 12 of 51. All products under Carver, Wax, Dental
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.