FDA.report

Nobel Biocare N1™

Primary DI
07332747162011
Brand
Nobel Biocare N1™
Company
Nobel Biocare AB
Model
300889
Catalog number
300889
Device description
OsseoShaper 1 Nobel Biocare N1™ 4.8x9mm
Published
2023-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
QRQNon-irrigation endosseous dental implant drill bits

Product Code Classifications

CodeDeviceSpecialtyClass
QRQNon-Irrigation Endosseous Dental Implant Drill BitsDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07332747162011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07332747162011073327471620117332747162011

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, single-useA 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
Length9Millimeter
Outer Diameter4.8Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry

Sterilization Methods

Method

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07332747222043NobelActive® S TiUltra™3022833022832026-02-26
07332747222050NobelActive® S TiUltra™3022843022842026-02-26
07332747222067NobelActive® S TiUltra™3022853022852026-02-26

Other Devices Sharing Product Codes

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00810157313898Step Drill 2.3/2.0Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313904Step Drill 2.8/2.3Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313911Step Drill 3.4/2.8Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313928Step Drill 3.8/3.4Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313935Step Drill 4.4/3.8Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313942Step Drill 4.8/4.4Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313959Step Drill 5.1/4.8Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313966Step Drill 5.4/5.1Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313027Lindemann DrillParagon Implant Mfg., LLCQRQ2025-12-30
00810157312952Ruby Hex DrillParagon Implant Mfg., LLCQRQ2025-12-29
00810157312969Ruby Hex DrillParagon Implant Mfg., LLCQRQ2025-12-29
00810157312938Ruby Hex DrillParagon Implant Mfg., LLCQRQ2025-12-24
00810157312945Ruby Hex DrillParagon Implant Mfg., LLCQRQ2025-12-24
00810157312631Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-18
00810157310101Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
00810157312594Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
00810157312600Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
00810157312617Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
00810157312624Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
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07290119310494Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
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