Is this your brand? Sign in to claim ownership.
Sign in to claim this brandSdi , Ltd.
US
Last updated May 23, 2026
What Sdi , Ltd. makes
Sdi, Ltd. manufactures a range of dental materials and devices, including pit and fissure sealants, glass ionomer cements, composite resins, amalgam alloys, dentine bonding agents, etching solutions, and polymerization lamps, as well as a general‑purpose brachytherapy system applicator for remote after‑loading.
All of these products are classified as Class II medical devices and are listed in the FDA UDI registry; the company is based in 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 Sdi, Ltd. manufacture?
Sdi, Ltd. produces dental materials such as pit/fissure sealants, glass ionomer cements, composite resins, amalgam alloys, dentine bonding agents, etching solutions, and polymerization lamps, plus a general‑purpose brachytherapy system applicator for remote after‑loading. This list comes directly from the provided device categories and example devices.
Where is Sdi, Ltd. based and where are its devices listed?
The company is based in the United States, as indicated by the COUNTRY field. All of its devices are recorded in the FDA UDI registry, which is the only registry mentioned in the LISTED IN section of the data.
How are Sdi, Ltd.’s devices classified under regulatory rules?
Every device mentioned for Sdi, Ltd. falls under Class II classification. This classification is explicitly stated in the DEVICE CLASSES line, meaning each product is considered a moderate‑risk medical device according to FDA rules.
Can you give examples of specific products Sdi, Ltd. offers?
Examples from the data include AURA, CONSEAL, RIVA SC, PERMITE, ICE, RIVA LC, RIVA SILVER, ALLOYBOND, and ROK. These names appear in the EXAMPLE DEVICES list and illustrate the range of dental and brachytherapy products the company markets.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (618)
Page 8 of 13| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Conseal | 7850006 | FDA UDI | Class II | Active |
| Gs80 | 4401202 | FDA UDI | Class II | Active |
| Permite | 4005000 | FDA UDI | Class II | Active |
| Permite | 4001202 | FDA UDI | Class II | Active |
| Set PP | SET PP OA3 SYR 2 PK | FDA UDI | Class II | Unknown |
| Lojic+ | 4225000 | FDA UDI | Class II | Active |
| Set PP | 8805104 | FDA UDI | Class II | Active |
| Gs80 | GS80 3SP SLOW 50 | FDA UDI | Class II | Unknown |
| Aura | AURA 20 COMP MC3 | FDA UDI | Class II | Active |
| Aura | AURA 20 COMP DC2 | FDA UDI | Class II | Unknown |
| Permite | 4021303 | FDA UDI | Class II | Active |
| Set | 8810000 | FDA UDI | Class II | Active |
| Riva Lc | RIVA LC A2 P/L KT | FDA UDI | Class II | Unknown |
| Rok | ROK 1 SYR C2 | FDA UDI | Class II | Active |
| Riva Sc | RIVA SC B3 REG 50 CAP | FDA UDI | Class II | Unknown |
| Aura | AURA 20 COMP MC5 | FDA UDI | Class II | Active |
| Wave | 8211101 | FDA UDI | Class II | Active |
| Ice | ICE 1 SYR A3 | FDA UDI | Class II | Active |
| Riva Sc | 8610522 | FDA UDI | Class II | Active |
| Permite | PERMITE 1SP ECT 50 | FDA UDI | Class II | Active |
| Riva Sc | 8620000 | FDA UDI | Class II | Active |
| Riva Sc | RIVA SC A3 P/L KT | FDA UDI | Class II | Unknown |
| Permite | PERMITE 5SP 500 | FDA UDI | Class II | Unknown |
| Lojic+ | 4223202 | FDA UDI | Class II | Active |
| Riva Lc | 8730003 | FDA UDI | Class II | Active |
| Aura | AURA SYR DB | FDA UDI | Class II | Unknown |
| Riva Sc | 8600011 | FDA UDI | Class II | Active |
| Gs80 | GS80 3SP REG 500 | FDA UDI | Class II | Unknown |
| Glacier | GLACIER 1 SYR A4 | FDA UDI | Class II | Active |
| Luna 2 | 8452025 | FDA UDI | Class II | Active |
| Set PP | 8805102 | FDA UDI | Class II | Active |
| Riva Bond | RIVA BOND LC P/L KT | FDA UDI | Class II | Unknown |
| Riva Sc | RIVA SC HV A3.5 50 CAP | FDA UDI | Class II | Unknown |
| Permite | 4022101 | FDA UDI | Class II | Active |
| Ice | ICE 1 SYR A2 | FDA UDI | Class II | Active |
| Permite | PERMITE 3SP SLOW 500 | FDA UDI | Class II | Unknown |
| Gs80 | 4405000 | FDA UDI | Class II | Active |
| Aura | AURA SYR MC4 | FDA UDI | Class II | Active |
| Riva Sc | RIVA SC B3 FAST 50 CAP | FDA UDI | Class II | Unknown |
| Set | SET A1 50 CAP | FDA UDI | Class II | Unknown |
| Riva Lc | RIVA LC A3.5 P/L KT | FDA UDI | Class II | Active |
| Set PP | 8810006 | FDA UDI | Class II | Active |
| Ice | ICE 20 COMP C1 | FDA UDI | Class II | Active |
| Wave | WAVE HV 1 SYR A3.5 | FDA UDI | Class II | Unknown |
| Glacier | GLACIER 1 SYR C3 | FDA UDI | Class II | Active |
| Glacier | GLACIER 1 SYR OC4 | FDA UDI | Class II | Active |
| Riva Protect | RIVA PROTECT P/L WHITE | FDA UDI | Class II | Unknown |
| Riva Lc | RIVA LC STARTER KT A2 | FDA UDI | Class II | Active |
| Gs80 | 4423404 | FDA UDI | Class II | Active |
| Riva Lc | RIVA LC C4 PWD REF 15G | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.