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Sign in to claim this brandKARL SCHUMACHER DENTAL INSTRUMENT CO., INC.
US
Last updated May 23, 2026
What KARL SCHUMACHER DENTAL INSTRUMENT CO., INC. makes
The company manufactures dental elevators for tooth and root extraction, collagen-based membranes for dental regeneration, and various bone matrix implants—both animal-derived and synthetic—for oral reconstruction. It also produces general oral wound dressings derived from animal sources, as well as reusable dental anaesthesia syringes.
These devices are regulated under FDA’s classification system as Class I, Class II, or Unclassified (U), with all products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Karl Schumacher Dental Instrument Co., Inc. manufacture?
Karl Schumacher Dental Instrument Co., Inc. specializes in dental devices, including tools for tooth and root extraction like dental elevators, regenerative materials such as collagen dental regeneration membranes, and bone matrix implants—both derived from animal sources and synthetic. They also produce oral wound dressings (animal-derived) and reusable dental anaesthesia syringes. These products focus on surgical, regenerative, and wound care applications in dentistry.
Where is Karl Schumacher Dental Instrument Co., Inc. based?
The company is headquartered in the United States. Its location influences regulatory compliance, as its devices fall under FDA jurisdiction, including classification and UDI requirements.
Which regulatory registries or databases list Karl Schumacher’s devices?
All of Karl Schumacher’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, enabling verification of device details like model, manufacturer, and classification.
How are Karl Schumacher’s dental devices classified under FDA regulations?
The company’s devices are classified as Class I, Class II, or Unclassified (U) under FDA guidelines. Class I devices generally pose minimal risk (e.g., reusable syringes), while Class II may require special controls (e.g., bone implants or membranes) due to moderate risk. Unclassified devices lack a predefined risk category but are still subject to FDA oversight.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 043957315
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Karl Schumacher XENOGRAFT | RBGP0510 | FDA UDI | Class II | Active |
| Karl Schumacher | 17.008.02 | FDA UDI | Class I | Active |
| Karl Schumacher | 17.007.05AE | FDA UDI | Class I | Active |
| Karl Schumacher | 17.007.04 | FDA UDI | Class I | Active |
| Karl Schumacher FOAM | RCWF0001 | FDA UDI | U | Active |
| Karl Schumacher SHIELD Plus | RCMS1520 | FDA UDI | Class II | Active |
| Karl Schumacher | 17.008.01 | FDA UDI | Class I | Active |
| Karl Schumacher FLEX | RCMF2030 | FDA UDI | Class II | Active |
| Karl Schumacher FLEX | RCMF1520 | FDA UDI | Class II | Active |
| Karl Schumacher | 17.008.08AE | FDA UDI | Class I | Active |
| Karl Schumacher XENOGRAFT | RBGP2020 | FDA UDI | Class II | Active |
| Karl Schumacher | 17.008.11 | FDA UDI | Class I | Active |
| Karl Schumacher | 17.008.09 | FDA UDI | Class I | Active |
| Karl Schumacher XENOGRAFT | RBGP4010 | FDA UDI | Class II | Active |
| Karl Schumacher | 17.008.04 | FDA UDI | Class I | Active |
| Karl Schumacher XENOGRAFT | RBGP2010 | FDA UDI | Class II | Active |
| Karl Schumacher | 17.007.05 | FDA UDI | Class I | Active |
| Karl Schumacher TAPE | RCWT0001 | FDA UDI | U | Active |
| Karl Schumacher | 17.008.05 | FDA UDI | Class I | Active |
| Karl Schumacher | 17.007.03 | FDA UDI | Class I | Active |
| Karl Schumacher | 17.008.08 | FDA UDI | Class I | Active |
| Karl Schumacher Composite Putty | RCBP0200 | FDA UDI | Class II | Active |
| Karl Schumacher SHIELD | RCMS1216 | FDA UDI | Class II | Active |
| Karl Schumacher | 17.008.06AE | FDA UDI | Class I | Active |
| Karl Schumacher Composite Putty | RCBP0050 | FDA UDI | Class II | Active |
| Karl Schumacher DRAPE | RCMD3040 | FDA UDI | Class II | Active |
| Karl Schumacher XENOGRAFT | RBGP1020 | FDA UDI | Class II | Active |
| Karl Schumacher XENOGRAFT | RBGP1010 | FDA UDI | Class II | Active |
| Karl Schumacher | 17.008.06 | FDA UDI | Class I | Active |
| Karl Schumacher | 17.007.02 | FDA UDI | Class I | Active |
| Karl Schumacher | SYR0001 | FDA UDI | Class II | Active |
| Karl Schumacher DRAPE | RCMD2030 | FDA UDI | Class II | Active |
| Karl Schumacher DRAPE | RCMD1520 | FDA UDI | Class II | Active |
| Karl Schumacher | 17.008.10 | FDA UDI | Class I | Active |
| Karl Schumacher | 17.007.01 | FDA UDI | Class I | Active |
| Karl Schumacher FLEX | RCMF3040 | FDA UDI | Class II | Active |
| Karl Schumacher | 17.008.09AE | FDA UDI | Class I | Active |
| Karl Schumacher XENOGRAFT in Syringe | RBGS0050 | FDA UDI | Class II | Active |
| Karl Schumacher PLUG | RCWP0001 | FDA UDI | U | Active |
| Karl Schumacher | 17.008.03 | FDA UDI | Class I | Active |
| Karl Schumacher Composite Putty | RCBP0100 | FDA UDI | Class II | Active |
| Karl Schumacher XENOGRAFT in Syringe | RBGS0025 | FDA UDI | Class II | Active |
| Karl Schumacher | 17.008.05AE | FDA UDI | Class I | Active |
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