FDA.reportPublic FDA data

Screw Removal Burr Guide

Primary DI
07290118145622
Brand
Screw Removal Burr Guide
Company
NOGA MEDICAL PRODUCTS LTD
Model
A
Catalog number
TK1-0036
Device description
Screw Removal Burr Guide
Published
2025-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290118145622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290118145622072901181456227290118145622

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
600763386
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290118144175CC Temporary Abutment H1mm PEEKAPT2-00012025-11-22
07290118144182CC Temporary Abutment H2mm PEEKAPT2-00022025-11-22
07290118144199CC Temporary Abutment H3mm PEEKAPT2-00032025-11-22
07290118144205CC 15° Temporary Abutment H1mm PEEKAPT2-00042025-11-22
07290118144212CC 15° Temporary Abutment H2mm PEEKAPT2-00052025-11-22
07290118144229CC 15° Temporary Abutment H3mm PEEKAPT2-00062025-11-22
07290118144236CC 25° Temporary Abutment H1mm PEEKAPT2-00072025-11-22
07290118144243CC 25° Temporary Abutment H2mm PEEKAPT2-00082025-11-22
07290118144250CC 25° Temporary Abutment H3mm PEEKAPT2-00092025-11-22
07290118145660CC Key 2.42 ShortATK2-00012025-11-22
07290118145677CC Key 2.42 LongATK2-00022025-11-22
07290118145684CC Implant IndicatorATK2-00052025-11-22
07290118145691CC Hand Tool 2.42 ShortATK2-00062025-11-22
07290118145707CC Hand Tool 2.42 LongATK2-00072025-11-22
07290118145714"CC 1/4"" Abutment Fixture Long"ATK2-00102025-11-22
07290118145721CC Handle Key 2.42mmATK2-00112025-11-22
07290118145738CC Screw Removal Burr GuideATK2-00122025-11-22
07290118145745CC Mock Abutment AnalogATK2-00142025-11-22
07290118145752CC Mock Abutment Analog 15°ATK2-00152025-11-22
07290118145769CC Mock Abutment Analog 25°ATK2-00162025-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06438311708775LMDentalLM-DentalDZN2026-05-25
06438311708782LMDentalLM-DentalDZN2026-05-25
06438311708799LMDentalLM-DentalDZN2026-05-25
06438311708805LMDentalLM-DentalDZN2026-05-25
06438311708676LMDentalLM-DentalDZN2026-03-23
06438311708683LMDentalLM-DentalDZN2026-03-23
06438311708690LMDentalLM-DentalDZN2026-03-23
06438311708706LMDentalLM-DentalDZN2026-03-23
06438311708713LMDentalLM-DentalDZN2026-03-23
06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
00348783008807Premier Cord PackersPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783008890Premier Cord PackersPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009552Premier SpatulaPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009569Premier SpatulaPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009859Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009897Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009903Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00840479202594RELIABOX PRE-PASTED STORAGE BOXRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479202600RELIABOX PRE-PASTED STORAGE BOXRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479203119RELIABOX ANTERIOR BRACKET HOLDING TWEEZERSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479203126RELIABOX POSTERIOR BRACKET HOLDING TWEEZERSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
10840481136013BULK EZZest Anchors, LLCDZN2026-03-10
00840479201054COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201061COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201078COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201085COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27