NBB External Hex

Primary DI
D985HE359050
Brand
NBB External Hex
Company
FUSION DENTAL IMPLANTS LLC
Model
3.5 Lock-Attach Abutment
Catalog number
HE35905
Device description
Lock-Attach Dental Implant Abutment
Published
2018-04-25
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
D985HE359050PrimaryHIBCC0

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
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
D985HE415500NBB External Hex4.1 Non Eng AbutmentHE415502018-04-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
04260516873062SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873079SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873086SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873109SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873116SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873338SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873345SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873352SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873369SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873376SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873628SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874465SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874472SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874533SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874540SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874557SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874564SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874571SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874700SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874717SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874724SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874731SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874748SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874755SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874809SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874816SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874830SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08