FDA.reportPublic FDA data

Drill ø3.80mm External Irrigation

Primary DI
07290118144328
Brand
Drill ø3.80mm External Irrigation
Company
NOGA MEDICAL PRODUCTS LTD
Model
A
Catalog number
TD1-0007
Device description
Drill ø3.80mm External Irrigation
Published
2024-12-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290118144328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290118144328072901181443287290118144328

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290118142560CC Direct Gold Plastic Cylinder With Hex.APF2-00532025-11-17
07290118142577CC Direct Gold Plastic Cylinder RoundAPF2-00542025-11-17
07290118142584CC Direct Gold Plastic Cylinder With Hex. W6mmAPF2-00552025-11-17
07290118142591CC Direct Gold Plastic Cylinder With Hex. W10mmAPF2-00562025-11-17
07290118142607CC Anatomic Restoration Kit H1mm L4mmAPF2-ARK142025-11-17
07290118142614CC Anatomic Restoration Kit H1mm L6mmAPF2-ARK162025-11-17
07290118142621CC Anatomic Restoration Kit H1mm L8mmAPF2-ARK182025-11-17
07290118142638CC Anatomic Restoration Kit H2mm L4mmAPF2-ARK242025-11-17
07290118142645CC Anatomic Restoration Kit H2mm L6mmAPF2-ARK262025-11-17
07290118142652CC Anatomic Restoration Kit H2mm L8mmAPF2-ARK282025-11-17
07290118142669CC Anatomic Restoration Kit H3mm L4mmAPF2-ARK342025-11-17
07290118142676CC Anatomic Restoration Kit H3mm L6mmAPF2-ARK362025-11-17
07290118142683CC Anatomic Restoration Kit H3mm L8mmAPF2-ARK382025-11-17
07290118142690CC Anatomic Restoration Kit H4mm L4mmAPF2-ARK442025-11-17
07290118142706CC Anatomic Restoration Kit H4mm L6mmAPF2-ARK462025-11-17
07290118142713CC Anatomic Restoration Kit H4mm L8mmAPF2-ARK482025-11-17
07290118142720CC Anatomic Restoration Kit H5mm L4mmAPF2-ARK542025-11-17
07290118142737CC Anatomic Restoration Kit H5mm L6mmAPF2-ARK562025-11-17
07290118142744CC Anatomic Restoration Kit H5mm L8mmAPF2-ARK582025-11-17
07290118142546CC Direct CoCr Plastic Cylinder With Hex. W6mmAPF2-00512025-11-13

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