FDA.reportPublic FDA data

LEVEL ONE ORTHOANCHOR

Primary DI
00888118037572
Brand
LEVEL ONE ORTHOANCHOR
Company
KLS-Martin L.P.
Model
25-301-06-09
Device description
PLATE, C TUBE, CROSS SHP, 12 MM BRG, 1.5 MM SCREW, CP TITANIUM
Published
2016-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118037572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118037572008881180375728881180375720888118037572

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic anchor plateA small metallic plate that is implanted intraorally to serve as a temporary anchor for an orthodontic device (e.g., a spring). It is available in various sizes and lengths and is anchored to the jawbone with dedicated bone screws. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118145819IPS60-011-13-09-LP2026-10-01
00888118145826IPS60-011-14-09-LP2026-10-01
00888118145833IPS60-011-15-09-LP2026-10-01
00888118145840IPS60-011-16-09-LP2026-10-01
00888118145857IPS60-011-17-09-LP2026-10-01
00888118145864IPS60-011-18-09-LP2026-10-01
00888118036261LEVEL ONE CMF25-038-30-092016-03-24
00888118036278LEVEL ONE CMF25-038-35-092016-03-24
00888118036285LEVEL ONE NEURO25-040-25-092016-03-24
00888118036292LEVEL ONE NEURO, STERILE25-040-25-712016-03-23
00888118036339LEVEL ONE CMF25-040-35-092016-03-24
00888118036346LEVEL ONE CMF25-040-40-092016-03-24
00888118036360LEVEL ONE NEURO25-042-02-092016-03-24
00888118036391LEVEL ONE NEURO25-042-05-092016-03-24
00888118036483LEVEL ONE CMF, STERILE25-042-20-712016-03-23
00888118092618LEVEL ONE CMF25-043-06-092016-03-24
00888118155498IPS60-500-15-092026-09-28
00888118155504IPS60-500-15-09-LP2026-09-28
00888118155511IPS60-500-15-09-PP2026-09-28
00888118155528IPS60-500-17-092026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114712149prosthetics - AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712767prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712774prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712781prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712798prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712804prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712811prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712828prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712835prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712842prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712859prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712866prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712873prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712880prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712897prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712903prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712910prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712927prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712934prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712941prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712958prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114712965prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713009prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713016prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713023prosthetics - AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713030prosthetics - AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713047prosthetics -TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713061prosthetics -TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713078prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06
07290114713085prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-06