FDA.reportPublic FDA data

Quantum

Primary DI
D82550214001530
Brand
Quantum
Company
QUANTUM BIOENGINEERING LTD.
Model
502-140-015-3
Catalog number
502-140-015-3
Device description
Multi Unit TL Abutment 4.0 -15° 3R
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
D82550214001530PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Millimeter
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
D82500515010030Quantum005-150-100-3005-150-100-32018-04-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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088000968585768plant Implant System8dent Inc.NHA2026-10-28
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088000968586068plant Implant System8dent Inc.NHA2026-10-28
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088000968604568plant Implant System8dent Inc.NHA2026-10-28
088000968604638plant Implant System8dent Inc.NHA2026-10-28
088000968650488plant Implant System8dent Inc.NHA2026-10-28
088000968650558plant Implant System8dent Inc.NHA2026-10-28
088000968650628plant Implant System8dent Inc.NHA2026-10-28
08809984971922S-PlantIDIS CO.,LTDNHA2026-10-26
088000968514098plant Implant System8dent Inc.NHA2026-10-23
088000968514168plant Implant System8dent Inc.NHA2026-10-23
088000968514238plant Implant System8dent Inc.NHA2026-10-23
088000968515468plant Implant System8dent Inc.NHA2026-10-23