FDA.reportPublic FDA data

NBB External Hex

Primary DI
D985HE415500
Brand
NBB External Hex
Company
FUSION DENTAL IMPLANTS LLC
Model
4.1 Non Eng Abutment
Catalog number
HE41550
Device description
Dental Implant abutment. non engaging
Published
2018-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K915375000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915375000ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEMOdontit Systeme1992-06-03DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D985HE415500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Basket 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 single, double, and/or triple contiguous cylinder(s) 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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081135800
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D985HE352000NBB External Hex3.5 Abutment ScrewHE352002018-05-30
D985HE354030NBB External Hex3.5 Healing AbutmentHE354032018-04-25
D985HE354050NBB External Hex3.5 Healing AbutmentHE354052018-04-25
D985HE355000NBB External Hex3.5 Eng AbutmentHE355002018-04-25
D985HE355500NBB External Hex3.5 Non Eng AbutmentHE355502018-04-25
D985HE356000NBB External Hex 3.5 Temp AbutmentHE356002018-04-25
D985HE358010NBB External Hex3.5 Multi-unit AbutmentHE358012018-04-26
D985HE358020NBB External Hex3.5 Multi-unit AbutmentHE358022018-04-26
D985HE358030NBB External Hex3.5 Multi-unit AbutmentHE358032018-04-26
D985HE359010NBB External Hex3.5 Lock-Attach AbutmentHE359012018-04-25
D985HE359020NBB External Hex3.5 Lock-Attach AbutmentHE359022018-04-25
D985HE359030NBB External Hex3.5 Lock-Attach AbutmentHE359032018-04-25
D985HE359040NBB External Hex3.5 Lock-Attach AbutmentHE359042018-04-25
D985HE359050NBB External Hex3.5 Lock-Attach AbutmentHE359052018-04-25
D985HE415000NBB External Hex4.1 Eng AbutmentHE415002018-04-26
D985HE415010NBB External Hex4.1 Eng Abutment 7mmHE415012018-04-26
D985HE415020NBB External Hex4.1 Eng Abutment 10mmHE415022018-04-26
D985HE416000NBB External Hex4.1 Temp AbutmentHE416002018-04-26
D985HE416100NBB External Hex4.1 Non Eng Temp AbutmentHE416102018-04-26
D985HE419010NBB External Hex4.1 Lock-Attach AbutmentHE419012018-04-26

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Primary DI, Brand, Company table
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