FDA.report

DIMPLO Fixture

Primary DI
08800362100293
Brand
DIMPLO Fixture
Company
DIMPLO Ltd.
Model
DF6008
Catalog number
DF6008
Published
2026-03-20
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
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions

SubmissionSupplement
K251605000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K251605000DIMPLO Implant SystemDIMPLO, Ltd.2025-12-22DZE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800362100293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800362100293088003621002938800362100293

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
963392194
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800362100002DIMPLO FixtureDFM3008DFM30082026-03-20
08800362100019DIMPLO FixtureDFM3010DFM30102026-03-20
08800362100026DIMPLO FixtureDFM3011DFM30112026-03-20
08800362100033DIMPLO FixtureDFM3013DFM30132026-03-20
08800362100040DIMPLO FixtureDFM3015DFM30152026-03-20
08800362100057DIMPLO FixtureDFM3508DFM35082026-03-20
08800362100064DIMPLO FixtureDFM3510DFM35102026-03-20
08800362100071DIMPLO FixtureDFM3511DFM35112026-03-20
08800362100088DIMPLO FixtureDFM3513DFM35132026-03-20
08800362100095DIMPLO FixtureDFM3515DFM35152026-03-20
08800362100101DIMPLO FixtureDF4008DF40082026-03-20
08800362100118DIMPLO FixtureDF4010DF40102026-03-20
08800362100125DIMPLO FixtureDF4011DF40112026-03-20
08800362100132DIMPLO FixtureDF4013DF40132026-03-20
08800362100149DIMPLO FixtureDF4015DF40152026-03-20
08800362100156DIMPLO FixtureDF4508DF45082026-03-20
08800362100163DIMPLO FixtureDF4510DF45102026-03-20
08800362100170DIMPLO FixtureDF4511DF45112026-03-20
08800362100187DIMPLO FixtureDF4513DF45132026-03-20
08800362100194DIMPLO FixtureDF4515DF45152026-03-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
088000968507858plant Implant System8dent Inc.DZE2026-03-24
088000968507928plant Implant System8dent Inc.DZE2026-03-24
088000968507788plant Implant System8dent Inc.DZE2026-03-23
08800362100002DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100019DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100026DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100033DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100040DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100057DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100064DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100071DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100118DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100125DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100132DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100149DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100156DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100163DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100170DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100187DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100194DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100200DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100217DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100224DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100231DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100248DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100255DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100262DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20