FDA device listing
K-00 - RUBBER DAM CLAMP BICUSPID #00,K-0 - RUBBER DAM CLAMP BICUSPID #0,K-12A - RUBBER DAM CLAMP MOLAR #12A,K-138…
FDA device listing 1817204873 · ASEPTICO, INC.
Key facts
| Proprietary names | K-00 - RUBBER DAM CLAMP BICUSPID #00,K-0 - RUBBER DAM CLAMP BICUSPID #0,K-12A - RUBBER DAM CLAMP MOLAR #12A,K-138 - RUBBER DAM CLAMP MOLAR #138,K-139 - RUBBER DAM CLAMP MOLAR # 139,K-13A - RUBBER DAM CLAMP MOLOR #13A,K-14A - RUBBER DAM CLAMP MOLAR #14A,K-14 - RUBBER DAM CLAMP MOLAR #14,K-15 - RUBBER DAM CLAMP MOLAR #15,K-18 - RUBBER DAM CLAMP MOLAR #18,K-1A - RUBBER DAM CLAMP BICUSPID #1,K-1… |
|---|---|
| Owner/operator | ASEPTICO, INC. |
| Owner/operator number | 3017604 |
| Product codes | EEF |
| Device names | EEF - Clamp, Rubber Dam |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6300 |
| Review panels | Dental |
| Registered establishments | ASEPTICO, INC. |
| Establishment registrations | 3017604 |
| FEI numbers | 3017604 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database