FDA.reportPublic FDA data

OSS Pick-up Impression Coping

Primary DI
08809918255005
Brand
OSS Pick-up Impression Coping
Company
Ossvis Co., Ltd.
Model
LWOPI55N
Device description
Dental Implant Accessories - Impression Coping
Published
2024-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809918255005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809918255005088099182550058809918255005

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
695365503
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809918274143LW Digital Lab Analog GMLWSDLAGM2026-04-20
08809918274150LW Narrow Dirigal Lab Analog GMLWNDLAGM2026-04-20
08809918274136Screw Remover TipHSRT2026-03-12
08809918274013LL Scan BodyLLMFSB2025-12-31
08809918259997LL Driver SeparatorHLLFRP2025-12-15
08809918274037Guide Full Flattening DrillHFD50GF2025-12-15
08809918274044Guide Full Lindemann DrillHLD1807GF2025-12-15
08809918274051Guide Full Lindemann DrillHLD1808GF2025-12-15
08809918274068Guide Full Lindemann DrillHLD1810GF2025-12-15
08809918274075Guide Full Lindemann DrillHLD1811GF2025-12-15
08809918274082Guide Full Lindemann DrillHLD1813GF2025-12-15
08809918274099Guide Full Cortical DrillHCD50GF2025-12-15
08809918274105Guide Full NoMount Driver EngineHNRSEGF2025-12-15
08809918274112Guide Full NoMount Driver EngineHNNRSEGF2025-12-15
08809918274129Guide Full Anchor Driver EngineHARSEGF2025-12-15
08809918274020LL Scan BodyLLMFSBPE2025-06-26
08809918209756LW Pre-milled AbutmentLWDPA1040HDB2024-12-18
08809918209763LW Pre-milled AbutmentLWDPA1040NDB2024-12-18
08809918209770LW Pre-milled AbutmentLWDPA1040HMX2024-12-18
08809918209787LW Pre-milled AbutmentLWDPA1040NMX2024-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
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EMKA013289MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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