Facility
SDI LTD.
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3004140838 |
|---|---|
| Establishment type | Manufacture Medical Device |
| Location | 3-15 BRUNSDON ST. BAYSWATER Victoria, AU 3153 |
| Registration status | Active · expires 2026 |
| Parent company | SDI LTD. (owner-operator 9002445) |
| Brand names | Adhesive 1; FROG; Go |
Devices registered here (2)
- Agent, Tooth Bonding, ResinProduct code KLE (opens in a new tab) · Class II · Dental · 21 CFR 872.3200
- Varnish, CavityProduct code LBH (opens in a new tab) · Class II · Dental · 21 CFR 872.3260
Recalls & enforcement
- Class IIOngoing2026-07-20Potential for electrical discharge from unit when unplugged.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-09-07. Verify this facility record at FDA → (opens in a new tab)
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