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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 5 of 13
DeviceModel / ReferenceRegistriesClassStatus
Ice ICE 20 COMP B3
FDA UDI
Class IIActive
Riva Sc RIVA SC A2 FAST 50 CAP
FDA UDI
Class IIUnknown
Permite PERMITE 1SP REG 50
FDA UDI
Class IIUnknown
Riva Protect 8695000
FDA UDI
Class IIActive
Riva Protect RIVA PROTECT PINK 50 CAP FAST
FDA UDI
Class IIUnknown
Aura 8565008
FDA UDI
Class IIActive
Riva Sc 8600008
FDA UDI
Class IIActive
Riva Sc RIVA SC HV A2 50 CAP
FDA UDI
Class IIUnknown
Glacier GLACIER COMP INTRO KT
FDA UDI
Class IIActive
Riva Protect RIVA PROTECT WHT 50 CAP FAST
FDA UDI
Class IIUnknown
Permite PERMITE 3SP ECT 50
FDA UDI
Class IIActive
Riva Protect 8690000
FDA UDI
Class IIActive
Riva Sc RIVA SC T-A3.5 FAST 50 CAP
FDA UDI
Class IIUnknown
Aura 8565004
FDA UDI
Class IIActive
Permite PERMITE 2SP SLOW 500
FDA UDI
Class IIUnknown
Conseal CONSEAL F SYR BULK KT
FDA UDI
Class IIUnknown
Aura 8565003
FDA UDI
Class IIActive
Aura 8565011
FDA UDI
Class IIActive
Riva Sc RIVA SC A3 PWD REF 15G
FDA UDI
Class IIUnknown
Permite PERMITE TABS FAST 5OZ
FDA UDI
Class IIActive
Aura AURA SYR BULK FILL
FDA UDI
Class IIUnknown
Gs80 4422303
FDA UDI
Class IIActive
Lojic+ LOJIC+ 3SP FAST 500
FDA UDI
Class IIUnknown
Gs80 4423202
FDA UDI
Class IIActive
Glacier GLACIER 1 SYR B2
FDA UDI
Class IIActive
Gs80 GS80 3SP FAST 500
FDA UDI
Class IIUnknown
Riva Lc 8700502
FDA UDI
Class IIActive
Wave 7512324
FDA UDI
Class IIActive
Ice ICE 20 COMP A4
FDA UDI
Class IIActive
Riva Sc 8605007
FDA UDI
Class IIActive
Set 8805001
FDA UDI
Class IIActive
Glacier GLACIER 5 SYR KT
FDA UDI
Class IIActive
Aura AURA SYR DC3
FDA UDI
Class IIUnknown
Riva Sc RIVA SC B2 REG 50 CAP
FDA UDI
Class IIUnknown
Glacier GLACIER 20 COMP D3
FDA UDI
Class IIActive
Riva Lc RIVA LC A3 PWD REF 15G
FDA UDI
Class IIUnknown
Wave WAVE MV 1 SYR A2
FDA UDI
Class IIUnknown
Rok ROK 1 SYR A3
FDA UDI
Class IIActive
Rok ROK SHADE GUIDE 5 SYR KT
FDA UDI
Class IIActive
S/Etch S/ETCH 10X2ML SYR KT
FDA UDI
Class IIUnknown
Gs80 GS80 1SP SLOW 50
FDA UDI
Class IIActive
Aura AURA COMP MULTIPURPOSE KIT
FDA UDI
Class IIActive
Aura AURA SYR STARTER KIT - MEDIUM
FDA UDI
Class IIActive
Wave WAVE BULK KT A1
FDA UDI
Class IIUnknown
Gs80 GS80 1SP FAST 500
FDA UDI
Class IIUnknown
Riva Luting 8651008
FDA UDI
Class IIActive
Riva Lc 8700012
FDA UDI
Class IIActive
Riva Lc RIVA LC HV B1 50 CAP
FDA UDI
Class IIUnknown
Wave WAVE MV 1 SYR A3.5
FDA UDI
Class IIUnknown
Gs80 4402202
FDA UDI
Class IIActive

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