Sterngold Implant System Guided Tissue Punch 3.5
Removes gingival tissue exposing the bone in preparation for osteotomy drilling.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Sterngold Dental LLC, United States |
|---|---|
| FDA product code | EME |
| Device type | Punch, Biopsy, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-06 |
| Record revised | 2025-08-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 905813 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 36 |
| Sklar Instruments | Sklar Corporation | 24 |
| Kohdent | Kohler Medizintechnik GmbH | 22 |
| Osung MND | Osung MND Co., Ltd. | 20 |
| Medline | Medline Industries, Inc. | 20 |
| Acu-Punch | Acuderm, Inc. | 17 |
| Gynex | Gynex Corporation | 13 |
| Exel Biopsy Punch | Exel Inc. | 11 |
| Shard | Applied Dental, Inc. | 9 |
| Biotanium | Basic Dental Implant Systems, Inc. | 7 |
| Punches, Nobel | Omnia Medical | 6 |
| Salvin Stainless Steel Multi-Use Rotary Tissue Punch – 4mm | Salvin Dental Specialties, LLC | 5 |
Showing 12 of 64. All products under Punch, Biopsy, Surgical
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.