FDA.reportPublic FDA data

NobelReplace®

Primary DI
07332747009637
Brand
NobelReplace®
Company
Nobel Biocare AB
Model
32300
Catalog number
32300
Device description
NOBELREPLACE® Tapered Surgery Kit
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
07332747009637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332747009637073327470096377332747009637

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant/prosthesis surgical procedure kitA collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. 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
true
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