Centurion
Strl Dental Extract Frcp, Unte Molar #23
7manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
Record
| Listed by | Centurion Medical Products Corporation, United States |
|---|---|
| FDA product code | OFX |
| Device type | General Purpose Dental Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Premarket notification | Exempt |
| Record published | 2022-01-01 |
| Record revised | 2022-06-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 24, case of 12, case of 50, case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DH830 | In distribution | |
| DH860A | In distribution | |
| DH810 | In distribution | |
| DH845 | In distribution | |
| I68945 | In distribution | |
| I86900 | In distribution | |
| DH775 | In distribution | |
| I68755 | In distribution | |
| DH860B | In distribution | |
| DH860 | In distribution | |
| DH855 | In distribution | |
| I68705 | In distribution | |
| DH835 | In distribution | |
| 9125ST6 | In distribution | |
| DH840 | In distribution | |
| DH815 | In distribution | |
| DP1020ST | In distribution | |
| DE5ST | In distribution | |
| DH760 | In distribution | |
| DH820A | In distribution | |
| I68960 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 813 |
| Medline Industries, Inc. | Medline Industries, Inc. | 287 |
| Stradis Healthcare | Stradis Healthcare | 69 |
| Stradis | Stradis Healthcare | 44 |
| Aligned Medical Solutions | Aligned Medical Solutions | 25 |
| ACS | American Contract Systems, Inc. | 25 |
| Medical Action Industries | Medical Action Industries, Inc. | 10 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 9 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 4 |
| DeRoyal | Deroyal Industries, Inc. | 3 |
| Regard™ | ROi CPS LLC | 2 |
| Henry Schein | Henry Schein, Inc. | 2 |
Showing 12 of 46. All products under General Purpose Dental Tray
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2024-02-23 | Class II | Process control | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. | 100 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-02-23 | Class II | Process control | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. | 2310 units |
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.