FDA.reportPublic FDA data

FEMALE OF DAL-BO STANDARD ABUTMENT

Primary DI
08435389802624
Brand
FEMALE OF DAL-BO STANDARD ABUTMENT
Company
BIOTECHNOLOGY INSTITUTE SL
Model
HTDS
Published
2015-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJXAnchor, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJXAnchor, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435389802624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435389802624084353898026248435389802624

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2156464067christinebattilana@bti-implant.us

Regulatory Flags#

DUNS number
461665312
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08435389828150SAMPLE PREPARATION KITKSAP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)CPUPC2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)CPUP2026-05-27
08435389830207STOP & GUIDE® BOXCCG2026-05-27
08435389830436EXTRA SHORT DRILL; Ø3.5 MMF35XS2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmTBA412026-05-27
08435389830542FLATTENING FRONT CUTTING DRILL; Ø3.1FCFA312026-05-27
08435389830559FLATTENING FRONT CUTTING SHORT DRILL; Ø3.1FCFA31C2026-05-27
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmTPMIEU12026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSFFXS2026-05-27
08435389831266FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0FCFA412026-05-27
08435389830825INTERNA 3.0 IMPLANT EXTENSION, 24 MMEAI3242026-03-31
08435389830832INTERNA 3.0 IMPLANT EXTENSION, 29 MMEAI3292026-03-31
08435389830849IMPLANT EXTENSION; INTERNA NARROW; 15MMINEAE152026-03-31
08435389830856INTERNA NARROW IMPLANT EXTENSION, 24 MMINEAE242026-03-31
08435389830863INTERNA NARROW IMPLANT EXTENSION, 29 MMINEAE292026-03-31
08435389830870INTERNA UNIVERSAL IMPLANT EXTENSOR, 15 MMINEAU152026-03-31
08435389830887INTERNA UNIVERSAL IMPLANT EXTENSOR , 24 MMINEAU242026-03-31
08435389830894INTERNA UNIVERSAL IMPLANT EXTENSOR, 29 MMINEAU292026-03-31
08435389828952EXTRACTOR FOR IMPLANTS 8EXIM82026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640239932098Dalbo®-PLUSCendres+Métaux SAEJX2026-02-16
07640239932104Dalbo®-PLUSCendres+Métaux SAEJX2026-02-16
08059224207810OT EQUATOR-EASY FIXRHEIN 83 SRLEJX2026-02-10
08059224208169OT EQUATOR-EASY FIXRHEIN 83 SRLEJX2026-02-10
08059224001661OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224108865OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224136905OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165189OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165196OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165202OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224166117OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168135OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168173OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168180OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224169910OT EQUATORRHEIN 83 SRLEJX2025-07-07
D990CTB1PK0Cementable TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PK0Pre-Coated TiBase 10PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKEX0Pre-Coated TiBase 10PK, Ext. ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKIT0Pre-Coated TiBase 10PK, Integrated ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKOA0Pre-Coated TiBase 10PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PK0Pre-Coated TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKEX0Pre-Coated TiBase 1PK, Ext. ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKIT0Pre-Coated TiBase 1PK, Integrated ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKOA0Pre-Coated TiBase 1PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990RKOA0Recharge Kit w/ Tall Spare Parts, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990RKPOCOA0Recharge Kit w/ POC, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990SFA10PKDKOA0Separable Fastener Assembly 10PK - Drill Kit Included, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990STB1PK0Standard TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990STB1PKOA0Standard TiBase 1PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990TC10PKOA0Temporary Cylinder 10PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19