FDA.reportPublic FDA data

Quantum

Primary DI
D8259601401000
Brand
Quantum
Company
QUANTUM BIOENGINEERING LTD.
Model
960-140-100
Catalog number
960-140-100
Device description
Rapid 4.0
Published
2018-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
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
K011223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011223000QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEMPaxmed International2001-09-20DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8259601401000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant/prosthesis surgical procedure kitA collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Millimeter
Outer Diameter2Millimeter

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
00842448118561TITAN IMPLANTS INC.TITAN IMPLANT INCNHA2026-09-06
00810125998713ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998720ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998737ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998744ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998751ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998768ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998775ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998782ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998799ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998805ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998812ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998829ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998836ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998843ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998850ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998867ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998874ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998881ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998898ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998904ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998911ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998928ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998935ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998942ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998959EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998966EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998973EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998980EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998997EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04