DEVICE: NA (07332747065497)
Device Identifier (DI) Information
NA
37094
In Commercial Distribution
37094
Nobel Biocare AB
37094
In Commercial Distribution
37094
Nobel Biocare AB
Dense Bone Drill Tapered NP 3.5x13 mm Single-Patient Use
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Fixture/appliance dental drill, single-use | A sterile shaft of metal (a drill bit) 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. It is typically made of a high-grade stainless steel alloy. 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 that is intended, in terms of sterility, for a single-patient use. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZI | DRILL, BONE, POWERED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 3.500 Millimeter |
Length: 13.000 Millimeter |
Device Record Status
2b6e55e4-2297-49db-a3d1-1b6aab61cd0e
March 29, 2018
2
September 17, 2016
March 29, 2018
2
September 17, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)322-5001
us.customerservice@nobelbiocare.com
us.customerservice@nobelbiocare.com