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Sdi , 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
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Website
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LinkedIn
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Facebook
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Email
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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
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Catalogue (618)

Page 7 of 13
DeviceModel / ReferenceRegistriesClassStatus
Wave 7514147
FDA UDI
Class IIActive
Gs80 GS80 2SP REG 50
FDA UDI
Class IIUnknown
Wave 8311101
FDA UDI
Class IIActive
Set PP 8805103
FDA UDI
Class IIActive
Rok ROK 1 SYR B1
FDA UDI
Class IIActive
Riva Sc 8610000
FDA UDI
Class IIActive
Lojic+ LOJIC+ 1SP FAST 500
FDA UDI
Class IIActive
Aura AURA SYR MC5
FDA UDI
Class IIActive
Riva Luting RIVA LUTING P/L TRIPLE PK
FDA UDI
Class IIUnknown
Ice ICE 1 SYR B3
FDA UDI
Class IIActive
S/Etch S/ETCH JUMBO 2X25ML SYR
FDA UDI
Class IIUnknown
Ice ICE 1 SYR B1
FDA UDI
Class IIActive
Wave 7514143
FDA UDI
Class IIActive
Wave WAVE 1 SYR I
FDA UDI
Class IIActive
Riva Sc 8610503
FDA UDI
Class IIActive
Wave 7500012
FDA UDI
Class IIActive
Radii RADII-CAL LED LGT ALL REG
FDA UDI
Class IIUnknown
Aura AURA 20 COMP DC5
FDA UDI
Class IIUnknown
Wave WAVE HV 1 SYR A2
FDA UDI
Class IIUnknown
Riva Lc 8700014
FDA UDI
Class IIActive
Riva Sc RIVA SC T-A3 P/L KT REG 15G
FDA UDI
Class IIUnknown
Permite PERMITE 3SP FAST 50
FDA UDI
Class IIUnknown
Wave WAVE BULK KT A3
FDA UDI
Class IIUnknown
Aura 8565108
FDA UDI
Class IIActive
Lojic+ LOJIC+ 2SP FAST 50
FDA UDI
Class IIUnknown
Riva Sc 8610501
FDA UDI
Class IIActive
Wave WAVE 1 SYR C3
FDA UDI
Class IIUnknown
Gs80 GS80 2SP FAST 500
FDA UDI
Class IIUnknown
Lojic+ 4222303
FDA UDI
Class IIActive
Go GO ! 5ML BTL KT
FDA UDI
Class IIActive
Aura AURA 20 COMP MC4
FDA UDI
Class IIActive
Gs80 GS80 1SP REG 50
FDA UDI
Class IIUnknown
Lojic+ LOJIC+ 2SP SLOW 50
FDA UDI
Class IIUnknown
Ice ICE 20 COMP OA2
FDA UDI
Class IIActive
Riva Sc RIVA SC A2 PWD REF 15G
FDA UDI
Class IIActive
Riva Sc RIVA SC A2 P/L KT
FDA UDI
Class IIUnknown
Riva Luting 8651508
FDA UDI
Class IIActive
Stela STELA CAPSULE REFILL 50 CAP
FDA UDI
Class IIUnknown
Riva Sc 8610504
FDA UDI
Class IIActive
Wave WAVE MV 1 SYR B2
FDA UDI
Class IIActive
Lojic+ LOJIC+ 5SP REG 500
FDA UDI
Class IIUnknown
Wave WAVE 1 SYR B2
FDA UDI
Class IIUnknown
Gs80 GS80 TABS REG 5OZ
FDA UDI
Class IIActive
Radii 5600102
FDA UDI
Class IIActive
Wave WAVE MV 20 COMP A3
FDA UDI
Class IIUnknown
Rok ROK 1 SYR A2
FDA UDI
Class IIActive
Permite PERMITE 2SP SC 50
FDA UDI
Class IIActive
Riva Luting RIVA LUTING PLUS PWD REF 25G
FDA UDI
Class IIUnknown
Riva Silver RIVA SILVER 50 CAP
FDA UDI
Class IIUnknown
Aura 8560006
FDA UDI
Class IIActive

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