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510(k) Data Aggregation
K Number
K222581Device Name
Stela Automix System
Manufacturer
SDI Limited
Date Cleared
2022-10-28
(63 days)
Product Code
EBF, KLE
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
SDI Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stela Primer:
- Dentin and enamel bonding
Stela Automix:
- Direct Class I, II, III and V cavities. Ideally Class I and II.
- Base or liner
- Core build-ups.
Device Description
The Stela Automix System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises:
- Stela Automix a double-barrel syringe containing two pastes which are mixed and dispensed with a single-use mixing tip and
- Stela Primer - an adhesive liquid packaged in a bottle. A bendable disposable brush applicator is used to apply Stela Primer.
The combination of Stela Primer and Stela Automix will bond to both enamel and dentin without scrubbing or light curing.
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K Number
K222583Device Name
Stela Capsule System
Manufacturer
SDI Limited
Date Cleared
2022-10-28
(63 days)
Product Code
EBF, KLE, REG
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
SDI Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stela Primer: - Dentin and enamel bonding
Stela Capsule - Direct Class I, II, III and V cavities. Ideally Class I and II - Base or liner - Core build-ups.
Device Description
The Stela Capsule System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises:
- Stela Capsule - a capsule consisting of powder and liquid components which are mixed and activated when the capsule is pushed down. After mixing with a triturator (amalgamator) an applicator is used to dispense the paste.
- Stela Primer an adhesive liquid packaged in a bottle. A bendable disposable brush applicator is used to apply Stela Primer.
The combination of Stela Primer and Stela Capsule will bond to both enamel and dentin without scrubbing or light curing.
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K Number
K214118Device Name
Riva Cem Automix
Manufacturer
SDI Limited
Date Cleared
2022-08-30
(243 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SDI Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Permanent cementation of:
- 1) Porcelain fused to metal (PFM) to crowns and bridges
- 2) Prefabricated/cast posts
- 3) Metals to crowns, bridges, inlays & onlays, orthodontic appliances & posts
- 4) Ceramics (high strength)* to crowns & bridges, inlays & onlays
- *E.g. Zirconia, Lithium Disilicate,
- 5) Ceramics (low strength)* to inlays
- *E.g. Feldspathic porcelains, Glass ceramics
Device Description
Riva Cem Automix™ is a radiopaque, fluoride releasing, resin modified glass ionomer luting cement.
Riva Cem Automix™ is intended for the cementation of crowns, bridges, inlays, posts (fibre-reinforced), and orthodontic appliances.
Riva Cem Automix™ consists of a base paste and a catalyst paste packaged in the automix delivery system for direct delivery in consistent mix ratios. Riva Cem Automix™ is available in a universal light-yellow shade in a double barrel syringe. The automix tip offers convenience over traditional hand mixed systems.
The product provides both self-cure and tack cure mechanisms which makes it versatile for the cementation of different restorative systems.
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K Number
K191656Device Name
Zipbond
Manufacturer
SDI Limited
Date Cleared
2019-12-02
(164 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
SDI Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Direct Applications:
- Light cured composite restorations
- Light cured compomers
- Cavity sealing prior to placement of indirect restorations
- Composite repair of porcelain and hybrid ceramic restorations
- Sealing exposed root surfaces which are causing hypersensitivity
- Core build ups using light cure/dual cure composites
- Protective varnish for glass ionomer (GI) filling
Indirect Applications:
- Cementation indirect restorations
Device Description
Zipbond is a single-component, (meth)acrylate-based material which functions as a combined etch-and-rinse (total-etch), self-etch and selective-etch dental adhesive. It offers an adhesive application technique for both direct indications and bonds to enamel, dentin, composites, cements. When used with a LED light curing device, Zipbond can be used with self-cure, dual-cure and light cure resin cements, composites and core-build up materials. Zipbond provides the operator with three choices of enamel and dentin pre-treatment: Self-etch mode: no phosphoric acid etching required prior to application, Selective-etch mode: selective phosphoric acid etching to enamel, Total-etch mode: phosphoric acid etching of both enamel and dentin.
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K Number
K172047Device Name
Riva Star
Manufacturer
SDI Limited
Date Cleared
2018-04-11
(279 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
SDI Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Treatment of dentinal hypersensitivity. For use in adults over the age of 21.
Device Description
Riva Star is a two-component device made up of Riva Star Step 1, containing silver diamine fluoride liquid, and Riva Star Step 2, containing aqueous potassium iodide liquid. Riva Star Step 1 silver diamine fluoride solution is applied to the tooth, immediately followed by Riva Star Step 2 aqueous potassium iodide, which forms an immediate reaction precipitate of silver iodide, thereby reducing tooth sensitivity by physically occluding the open dentinal tubules. Riva Star as well as predicates are liquids or gels that are applied to the teeth using an applicator brush or similar application.
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K Number
K102984Device Name
AURA
Manufacturer
SDI LIMITED
Date Cleared
2010-12-08
(62 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
SDI LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Direct anterior/posterior restorations and veneers. Core build ups. Indirect inlays, onlays and veneers. Splinting. Composite and porcelain repair. Sandwich technique with glass ionomers. For professional use only.
Device Description
Not Found
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