FDA.report

GBR Screw

Primary DI
08806169157232
Brand
GBR Screw
Company
DENTIS CO. ,LTD
Model
DBS1405
Device description
GBR Screw / DBS1405
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DZLScrew, Fixation, Intraosseous

Product Code Classifications

CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2

Premarket Submissions

SubmissionSupplement
K222367000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222367000SAVE GBRDentis Co., Ltd.2023-03-23DZL

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08806169157232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08806169157232088061691572328806169157232

GMDN Terms

TermDefinition
Membrane fixation tack, non-bioabsorbableA sterile non-bioabsorbable tack intended to be driven into bone to fix or stabilize bioabsorbable barrier membranes used for the regeneration of tissue and/or bone in the oral cavity, or used for other clinical situations that require membrane utilization. The device is typically made of metal (e.g., titanium alloy). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
694721181
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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