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Sign in to claim this brandZoll-Dental
US
Last updated May 24, 2026
What Zoll-Dental makes
The company manufactures reusable and single-use dental instruments, including tooth and root elevators for extraction, manual scalers for plaque removal, orthopaedic osteotomes for bone surgery, forceps for tooth removal, surgical scissors for cutting tissue, retractors to hold back gum tissue, and periosteal elevators for surgical exposure. Additional products include reusable amalgam carvers for dental restorations, designed for precision in dental procedures.
All listed devices fall under Class I regulatory classification in the US, with authorisation via the FDA’s UDI (Unique Device Identification) system. The company’s instruments are registered under this framework, ensuring compliance with US medical device regulations.
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 Zoll-Dental manufacture?
Zoll-Dental specializes in dental instruments, including reusable and single-use tools like tooth and root elevators for extractions, manual dental scalers for plaque removal, orthopaedic osteotomes for bone surgery, tooth extraction forceps, surgical scissors, retractors for gum exposure, and periosteal elevators. They also produce reusable amalgam carvers for precise dental restorations. These devices are designed for various dental and orthopaedic procedures.
Where is Zoll-Dental based, and what does that mean for its regulatory compliance?
Zoll-Dental is based in the United States, which means its devices are subject to FDA regulations. Since all listed devices fall under Class I classification, they are authorised through the FDA’s UDI (Unique Device Identification) system, ensuring compliance with US medical device requirements. The UDI system helps track and identify devices throughout their lifecycle.
Which regulatory registries or databases list Zoll-Dental’s devices?
Zoll-Dental’s devices are registered in the FDA’s UDI (Unique Device Identification) system, which is a centralised database for tracking and identifying medical devices in the US. This system ensures transparency and traceability for Class I devices, including those manufactured by Zoll-Dental.
How are Zoll-Dental’s devices classified under US regulations?
All of Zoll-Dental’s listed devices are classified as Class I under US regulations. This classification applies to low-risk devices like dental instruments, which typically require less stringent premarket review. Authorisation is granted through the FDA’s UDI system, ensuring compliance without additional approval processes beyond registration.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- zolldental.com
- —
- —
- [email protected]
- Phone
- +1(847)647-1819
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 005449822
Catalogue (2305)
Page 15 of 47| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Zoll-Dental | GK-AIK-2 | FDA UDI | Class I | Active |
| Zoll Dental | PET-6 | FDA UDI | Class I | Active |
| Zoll-Dental | PE-KN1 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-5802 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-1178 | FDA UDI | Class I | Unknown |
| Zoll-Dental | Sti-NE1O | FDA UDI | Class I | Active |
| Zoll-Dental | ELELT-5ICF | FDA UDI | Class I | Active |
| Zoll Dental | Z-4820505 | FDA UDI | Class I | Active |
| Zoll Dental | GK-TUN-K7 | FDA UDI | Class I | Active |
| Zoll-Dental | CURESC-15SLC | FDA UDI | Class I | Active |
| Zoll-Dental | S-YG15 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-1157 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-9013 | FDA UDI | Class I | Active |
| Zoll Dental | Z-5528 | FDA UDI | Class I | Active |
| Zoll-Dental | ELE-B4394 | FDA UDI | Class I | Active |
| Zoll-Dental | OST-NBRTC-OFCT4.4 | FDA UDI | Class I | Active |
| Zoll-Dental | S-SP2/3 | FDA UDI | Class I | Active |
| Zoll-Dental | OPCD-Leg1 | FDA UDI | Class I | Active |
| Zoll Dental | Z-9615 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-19-274-16 | FDA UDI | Class I | Active |
| Zoll-Dental | OPEXC-63/64 | FDA UDI | Class I | Active |
| Zoll-Dental | COMP-3 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-5596 | FDA UDI | Class I | Active |
| Zoll-Dental | OPAC-AWMini | FDA UDI | Class I | Active |
| Zoll-Dental | Z-4072 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-6525 | FDA UDI | Class I | Unknown |
| Zoll-Dental | ELE-SA-8 | FDA UDI | Class I | Active |
| Zoll-Dental | OST-3IOC-OFB4.40 | FDA UDI | Class I | Active |
| Zoll-Dental | OPB-PKT-3R | FDA UDI | Class I | Active |
| Zoll-Dental | Z-9981 | FDA UDI | Class I | Active |
| Zoll-Dental | PE-Z3/PR3S | FDA UDI | Class I | Active |
| Zoll-Dental | S-GRAS13/14 | FDA UDI | Class I | Active |
| Zoll-Dental | EXPDE-DG16 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-6481 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-4195 | FDA UDI | Class I | Unknown |
| Zoll-Dental | Z-12TKP | FDA UDI | Class I | Active |
| Zoll-Dental | Z-1163 | FDA UDI | Class I | Active |
| Zoll-Dental | S-CK6 | FDA UDI | Class I | Active |
| Zoll-Dental | CURE-M8 | FDA UDI | Class I | Active |
| Zoll-Dental | RET-K2 | FDA UDI | Class I | Active |
| Zoll-Dental | S-CAT107/108 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-7200 | FDA UDI | Class I | Active |
| Zoll-Dental | ELE-C22 | FDA UDI | Class I | Active |
| Zoll Dental | ELE-Z12B | FDA UDI | Class I | Active |
| Zoll-Dental | S-U15 | FDA UDI | Class I | Active |
| Zoll-Dental | S-GRA11/12 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-6511 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-9503 | FDA UDI | Class I | Active |
| Zoll-Dental | PE-Z2 | FDA UDI | Class I | Active |
| Zoll-Dental | Z-6506 | FDA UDI | Class I | Unknown |
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