Healing Cap

Primary DI
08800053012478
Brand
Healing Cap
Company
DENTIS CO. ,LTD
Model
DGHCN5504
Device description
Healing Cap / DGHCN5504
Published
2023-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MHAHyperthermia By Ultrasound For Brain Tumor Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHAHyperthermia By Ultrasound For Brain Tumor Therapy

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222451000SAVE GBRDentis Co., Ltd.2023-02-07NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800053012478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800053012478088000530124788800053012478

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
694721181
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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08800313235715SQ AXEL Guide CountersinkDSAGCS502026-07-09
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08800313235784SQ AXEL Guide Step DrillDSAGSTD50102026-07-09
08800313235791SQ AXEL Guide Step DrillDSAGSTD50082026-07-09
08800313235807SQ AXEL Guide Step DrillDSAGSTD46162026-07-09
08800313235814SQ AXEL Guide Step DrillDSAGSTD46142026-07-09
08800313235821SQ AXEL Guide Step DrillDSAGSTD46122026-07-09
08800313235838SQ AXEL Guide Step DrillDSAGSTD46102026-07-09
08800313235845SQ AXEL Guide Step DrillDSAGSTD46082026-07-09
08800313235852SQ AXEL Guide Step DrillDSAGSTD42162026-07-09
08800313235869SQ AXEL Guide Step DrillDSAGSTD42142026-07-09
08800313235876SQ AXEL Guide Step DrillDSAGSTD42122026-07-09
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08800313235890SQ AXEL Guide Step DrillDSAGSTD42082026-07-09
08800313235906SQ AXEL Guide Step DrillDSAGSTD38162026-07-09