FDA.reportPublic FDA data

Quantum

Primary DI
D82500515010030
Brand
Quantum
Company
QUANTUM BIOENGINEERING LTD.
Model
005-150-100-3
Catalog number
005-150-100-3
Device description
Healing Plug Abutment 5.0 3S
Published
2018-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

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
K112279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112279000QUANTUM DENTAL IMPLANT SYSTEMQuantum Bioengineering, Ltd.2012-05-04DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D82500515010030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, reusableA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Millimeter
Outer Diameter3Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(954)474-2556info@quantumimplants.com

Regulatory Flags#

DUNS number
797604456
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8250051501000Quantum005-150-100005-150-1002018-04-12
D82500516010030Quantum005-160-100-3005-160-100-32018-04-12
D8250061351000Quantum006-135-100006-135-1002018-04-12
D82500613510030Quantum006-135-100-3006-135-100-32018-04-12
D8250061401000Quantum006-140-100006-140-1002018-04-12
D82500614010030Quantum006-140-100-3006-140-100-32018-04-12
D8250061501000Quantum006-150-100006-150-1002018-04-12
D82500615010030Quantum006-150-100-3006-150-100-32018-04-12
D82500616010030Quantum006-160-100-3006-160-100-32018-04-12
D8250501351000Quantum050-135-100050-135-1002018-04-12
D8250501401000Quantum050-140-100050-140-1002018-04-12
D82505014010030Quantum050-140-100-3050-140-100-32018-04-12
D8250501501000Quantum050-150-100050-150-1002018-04-12
D82505015010030Quantum050-150-100-3050-150-100-32018-04-12
D82505016010030Quantum050-160-100-3050-160-100-32018-04-12
D8250601351000Quantum060-135-100060-135-1002018-04-12
D82506013510030Quantum060-135-100-3060-135-100-32018-04-12
D8250601401000Quantum060-140-100060-140-1002018-04-12
D82506014010030Quantum060-140-100-3060-140-100-32018-04-12
D8250601501000Quantum060-150-100060-150-1002018-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842092174999PreatPreat CorporationNHA2026-06-09
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