FDA.report

INNO SLA Submerged Narrow Implant System-Pre-Mount Type Fixture

Primary DI
08800016102246
Brand
INNO SLA Submerged Narrow Implant System-Pre-Mount Type Fixture
Company
Cowellmedi Co.,Ltd
Model
SR3108NS
Published
2024-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions

SubmissionSupplement
K231395000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231395000INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.2023-10-18DZE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800016102246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800016102246088000161022468800016102246

GMDN Terms

TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods

Method

Regulatory Flags

DUNS number
688753763
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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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