FDA.reportPublic FDA data

NA

Primary DI
07332747032475
Brand
NA
Company
Nobel Biocare AB
Model
36724
Catalog number
36724
Device description
Bone Mill with Guide CC RP
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZIDRILL, BONE, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332747032475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332747032475073327470324757332747032475

GMDN Terms#

Term, Definition table
TermDefinition
Manual bone millA manually-operated, non-patient-contact device intended to be used to grind bone into a slurry or a powder for use as a bone matrix for bone regeneration or bone grafting. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332747225549NobelActive®3025653025652026-03-02
07332747225556NobelActive®3025663025662026-03-02
07332747225563NA3025673025672026-03-02
07332747225570NA3025683025682026-03-02
07332747225587NA3025693025692026-03-02
07332747225594NA3025703025702026-03-02
07332747225839NobelActive®3025833025832026-03-02
07332747221947NobelActive® S TiUltra™3022733022732026-02-26
07332747221954NobelActive® S TiUltra™3022743022742026-02-26
07332747221961NobelActive® S TiUltra™3022753022752026-02-26
07332747221978NobelActive® S TiUltra™3022763022762026-02-26
07332747221985NobelActive® S TiUltra™3022773022772026-02-26
07332747221992NobelActive® S TiUltra™3022783022782026-02-26
07332747222005NobelActive® S TiUltra™3022793022792026-02-26
07332747222012NobelActive® S TiUltra™3022803022802026-02-26
07332747222029NobelActive® S TiUltra™3022813022812026-02-26
07332747222036NobelActive® S TiUltra™3022823022822026-02-26
07332747222043NobelActive® S TiUltra™3022833022832026-02-26
07332747222050NobelActive® S TiUltra™3022843022842026-02-26
07332747222067NobelActive® S TiUltra™3022853022852026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E322033800150MECTRONMECTRON SPADZI2026-02-18
E322033800160MECTRONMECTRON SPADZI2026-02-18
E322034000110MECTRONMECTRON SPADZI2026-02-18
E322034000120MECTRONMECTRON SPADZI2026-02-18
E322034000130MECTRONMECTRON SPADZI2026-02-18
E322048000111010MECTRONMECTRON SPADZI2026-02-18
E322048000121010MECTRONMECTRON SPADZI2026-02-18
00810044841459Round Bur one size lengthOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842722HexaPLUS Sinus Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842739HexaPLUS Sinus Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842845OnePLUS Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842852OnePLUS Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842869OnePLUS Dental ImplantOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843125HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843132HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843149HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843156HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843163HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843170HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843187HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843194HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843200HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044843224HexaPLUS S OneDrill Implant SystemOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-25
00810044842142OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842159OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842166OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842173OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842180OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842197OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24
00810044842203OneDrill Surgical DrillOSSEOFUSE INTERNATIONAL, INC.DZI2025-11-24