FDA.report

MILLABLE TITANIUM ABUTMENT

Primary DI
D7701286893
Brand
MILLABLE TITANIUM ABUTMENT
Company
SWEDEN & MARTINA SPA
Model
AS-CAMTABU425-CRE
Catalog number
AS-CAMTABU425-CRE
Device description
MILLABLE TITANIUM ABUTMENT D.4.25 EX 2.30
Published
2017-01-25
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
true

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7701286893PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
844.862.7846info.us@sweden-martina.com

Regulatory Flags

DUNS number
433815198
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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

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D7702749733MASTER SLEEVEGS-B-50WGS-B-50W2025-12-16
D7702749743MASTER SLEEVEGS-B-50W-6GS-B-50W-62025-12-16
D7702749753MASTER SLEEVEGS-B-50W-SETGS-B-50W-SET2025-12-16
D7702707123STARTER PACK B4USTARTER-PACK-B4U.STARTER-PACK-B4U.2025-09-26
D7701556003PRAMA RF IMPLANT ZIRTILS-ZT-380SL-180LS-ZT-380SL-1802025-08-04
D7701556073PRAMA RF IMPLANT ZIRTILS-ZT-425SL-180LS-ZT-425SL-1802025-08-04
D7701609403STOP FOR CONICAL DRILL STOP-2025-180-SWSTOP-2025-180-SW2025-07-24
D7701609413STOP FOR CONICAL DRILL STOP-2025-190-SWSTOP-2025-190-SW2025-07-24
D7701609433STOP FOR CONICAL DRILL STOP-2025-210-SWSTOP-2025-210-SW2025-07-24
D7701609443STOP FOR CONICAL DRILL STOP-2025-220-SWSTOP-2025-220-SW2025-07-24
D7701609463STOP FOR CONICAL DRILL STOP-2025-240-SWSTOP-2025-240-SW2025-07-24
D7701609483STOP FOR CONICAL DRILL STOP-2025-260-SWSTOP-2025-260-SW2025-07-24
D7701609513CYLINDRICAL DRILLFP-200-L-SWFP-200-L-SW2025-07-24
D7701609523CONICAL DRILLFK250-L-SWFK250-L-SW2025-07-24
D7701609693FINAL CONICAL DRILLFK380-L-SWFK380-L-SW2025-07-24
D7701609703FINAL CONICAL DRILLFK425-L-SWFK425-L-SW2025-07-24
D7701609733STOP FOR CONICAL DRILL STOP-3842-180-SWSTOP-3842-180-SW2025-07-24
D7701609743STOP FOR CONICAL DRILL STOP-3842-190-SWSTOP-3842-190-SW2025-07-24
D7701609763STOP FOR CONICAL DRILL STOP-3842-210-SWSTOP-3842-210-SW2025-07-24
D7701609773STOP FOR CONICAL DRILL STOP-3842-220-SWSTOP-3842-220-SW2025-07-24

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