FDA.report

Titanium screw M 1.4 x 3.5 mm

Primary DI
EBRE3300K7109
Brand
Titanium screw M 1.4 x 3.5 mm
Company
bredent GmbH & Co. KG
Model
3300K710
Catalog number
3300K710
Device description
Titanium screw M 1.4 x 3.5 mm 10 Pieces
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EBLPIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS

Product Code Classifications

CodeDeviceSpecialtyClass
EBLPin, Retentive And Splinting, And Accessory InstrumentsDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EBRE3300K7109PackageHIBCC1Not in Commercial Distribution
EBRE3300K7100PrimaryHIBCC0
EBRE3300K7108Unit of UseHIBCC0

GMDN Terms

TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Device Sizes

TypeValueUnit
Outer Diameter2.3Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+4907309872451info@bredent.com

Regulatory Flags

DUNS number
341086190
Device count
10
DM exempt
false
Premarket exempt
true
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
false

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