FDA.reportPublic FDA data

WAVE

Primary DI
09336472013257
Brand
WAVE
Company
SDI LIMITED
Model
8300000
Catalog number
8300000
Device description
WAVE MV INTRO KT
Published
2025-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, tooth shade, resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973091000WAVESouthern Dental Industries, Inc.1997-12-08EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09336472013257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09336472013257093364720132579336472013257

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage conditions 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
753221852
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
29336472004747BENCO ADMIX510230351023032026-02-17
29336472004754BENCO SPHERICAL510236351023632026-02-17
29336472004860BENCO ADMIX512230351223032026-02-17
29336472004877BENCO SPHERICAL512236351223632026-02-17
09336472005450RIVA CEM AUTOMIX880070488007042026-02-16
09336472005474ULTRAMAT 2554604555460452026-02-16
09336472020965RIVA CEM AUTOMIX880070388007032026-02-16
09336472032203RIVA CEM880070088007002026-02-16
09336472038212RIVA STAR880050488005042026-02-16
09336472038366RIVA STAR AQUA880052788005272026-02-16
09336472038403RIVA STAR AQUA880053288005322026-02-16
09336472038441RIVA STAR880053788005372026-02-16
D662070830158PD ADMIX400002540000252026-02-17
D662070830166PD ADMIX400002640000262026-02-17
D662070830273PD ADMIX400000540000052026-02-17
D662070830281PD ADMIX400000640000062026-02-17
D662070900258PD SPHERICAL400006540000652026-02-17
D662070900266PD SPHERICAL400006640000662026-02-17
D662070900373PD SPHERICAL400004540000452026-02-17
D662070900381PD SPHERICAL400004640000462026-02-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809518340668Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809254453875Dual CoreVERICOM CO., LTD.EBF2026-05-27
08809254453943Dual CoreVERICOM CO., LTD.EBF2026-05-27
07615208291964Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
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07615208291995Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292008Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292015Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
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