Integra® Miltex®
Periotome Kit, Set of 3 Blades: Straight, Hatchet, Hoe with Thompson™ Slimline 7 Cassette
2manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Yichuan Plastic Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 8 |
| Yangzhou Xintaiyang Plastic Daily Chemical Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 7 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EMQ |
| Device type | Hoe, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-18 |
| Record revised | 2022-07-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70-172 | Withdrawn | |
| THHO812 | Withdrawn | |
| THHO12KK | Withdrawn | |
| 70-171 | Withdrawn | |
| 70-170 | Withdrawn | |
| RHHO12 | Withdrawn | |
| THHO13 | Withdrawn | |
| 70-177 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing, Inc. | Nordent Manufacturing Inc | 56 |
| Power Dental USA | Power Dental U.S.A. Inc. | 54 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 29 |
| American Eagle Instruments | American Eagle Instruments | 8 |
| Zoll-Dental | Zoll-Dental | 8 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 7 |
| Blue AND Green | Nordent Manufacturing Inc | 3 |
| Anatomic Colours | Aesculap AG | 2 |
| Quinelato | Schobell Industrial Ltda | 1 |
| Henry Schein | Henry Schein, Inc. | 1 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 1 |
| Chisel 7-10 D/E Round Handle | W.H. Holden, Inc. | 1 |
Showing 12 of 14. All products under Hoe, Periodontic
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.