FDA.report

NA

Primary DI
07332747006391
Brand
NA
Company
Nobel Biocare AB
Model
28861
Catalog number
28861
Device description
Trephine Drill 5.2/6.2 mm
Published
2016-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZIDRILL, BONE, POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07332747006391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07332747006391073327470063917332747006391

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, single-useA sterile shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter5.2Millimeter
Outer Diameter6.2Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)322-5001us.customerservice@nobelbiocare.com

Regulatory Flags

DUNS number
353939929
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

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