FDA.reportPublic FDA data

NBB External Hex

Primary DI
D985HE359040
Brand
NBB External Hex
Company
FUSION DENTAL IMPLANTS LLC
Model
3.5 Lock-Attach Abutment
Catalog number
HE35904
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
D985HE359040PrimaryHIBCC0

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
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
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
05712821014696Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014740Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014757Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014764Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014771Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014788Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014795Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014801Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014818Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014825Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014832Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014849Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014856Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014863Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014870Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014887Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014894Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014900Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014917Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014924Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014931Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014948Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014955Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014962Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014979Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014986Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06