FDA.report

Solid Lab Analog

Primary DI
08809918230668
Brand
Solid Lab Analog
Company
Ossvis Co., Ltd.
Model
LWSLA704
Device description
Dental Implant Accessories - Lab Analog
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809918230668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809918230668088099182306688809918230668

GMDN Terms

TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
695365503
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08809918274105Guide Full NoMount Driver EngineHNRSEGF2025-12-15
08809918274112Guide Full NoMount Driver EngineHNNRSEGF2025-12-15
08809918274129Guide Full Anchor Driver EngineHARSEGF2025-12-15
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08809918209756LW Pre-milled AbutmentLWDPA1040HDB2024-12-18
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08809918209770LW Pre-milled AbutmentLWDPA1040HMX2024-12-18
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Primary DIBrandCompanyProduct codePublished
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08800020802842ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
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08800020802873SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
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08800020802996SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
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