FDA.report

ITL Dental

Primary DI
00817686021997
Brand
ITL Dental
Company
EMERY ENTERPRISES INC
Model
BWS-4020 Ball Attachment Screw, 4.5 Pla
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817686021997PrimaryGS10

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
836292029
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00817686020006ITLDentalSMS-60312024-03-29
00817686023779ITLDentalSMS-60332024-03-29
00817686023830ITLDentalGTW-302024-03-29
00817686023854ITLDentalGTW 352024-03-29
00817686024066ITLDentalH-25L2024-03-29
00817686024295ITLDentalH-25LS2024-03-29
00817686024301ITLDentalH-25LL2024-03-29
00817686025704ITLDentalSMS-60342024-03-29
00817686029009ITLDentalATWS2024-03-29
00817686029016ITLDentalBEK-22024-03-29
00817686029023ITLDentalGTW-35D2024-03-29
00817686029047ITLDentalTSU-10432024-03-29
00817686029054ITLDentalTSU-10552024-03-29
00817686029085ITLDentalSMS-00312024-03-29
00817686029092ITLDentalSMS-00322024-03-29
00817686029108ITLDentalSMS-00332024-03-29
00817686029115ITLDentalSMS-00342024-03-29
00817686029122ITLDentalSBT-10562024-03-29
00817686029139ITLDentalSDAS-10572024-03-29
00817686029146ITLDentalSMU-50222024-03-29

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