Premier Dilator
Dilator Kleegman Narrow Ptfe
3manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Zhejiang (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 |
| Wenzhou LW Wewear Accessories Co., Ltd. | Wenzhou | Zhejiang | Private-label distributor | 2 |
Record
| Listed by | Premier Dental Products Co., United States |
|---|---|
| FDA product code | HDQ |
| Device type | Dilator, Cervical, Fixed Size |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-06-08 |
| Record revised | 2026-06-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2026-06-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1030588 | In distribution | |
| 1030585 | In distribution | |
| 1030582 | In distribution | |
| 1030586 | In distribution | |
| 1030587 | In distribution | |
| 1030581 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hayden Medical | Hayden Medical Inc | 184 |
| Millennium | Avalign Technologies, Inc. | 181 |
| Elmed Incorporated | Elmed, Inc. | 152 |
| Marina Medical | Marina Medical Instruments, Inc. | 142 |
| Elmed | Elmed, Inc. | 138 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 129 |
| Ambler Surgical | Ambler Surgical, LLC | 103 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 100 |
| Aesculap | Aesculap AG | 98 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 77 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 73 |
| V. Mueller | Steris Corporation | 65 |
Showing 12 of 104. All products under Dilator, Cervical, Fixed Size
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.