FDA.reportPublic FDA data

LL Temporary Cap

Primary DI
08809918249943
Brand
LL Temporary Cap
Company
Ossvis Co., Ltd.
Model
LLMFTC
Device description
Dental Implant Abutment
Published
2024-11-29
Public version status
Update
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242379000LL Implant SystemOssvis Co., Ltd.2024-11-07DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809918249943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809918249943088099182499438809918249943

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
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
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
04260516873062SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873079SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873086SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873109SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873116SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873338SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873345SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873352SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873369SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873376SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873628SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874465SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874472SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874533SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874540SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874557SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874564SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874571SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874700SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874717SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874724SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874731SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874748SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874755SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874809SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874816SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874830SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08