FDA.report

SET ZZ BASE F-DA-CCTB BBAN

Primary DI
D800BSAD8231
Brand
SET ZZ BASE F-DA-CCTB BBAN
Company
ZIRKONZAHN SRL
Model
BSAD8231
Device description
SET ZZ BASE F-DA-CCTB BBAN (Conical cemented titan base non hex and screw). The ZZ Base for MUA are prosthetic interfaces that are used as coping for multi-unit abutments. The dental restoration is adhesively cemented to the ZZ Base for MUA to ensure a solid connection between the multi-unit restoration and the multi-unit abutment.
Published
2020-09-24
Public version status
New
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

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D800BSAD8231PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
564251911
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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D800DSCL9516C030Abro® Basic Multistratum® C3 95H16DSCL9516C032025-04-04
D800DSCL9516C040Abro® Basic Multistratum® C4 95H16DSCL9516C042025-04-04
D800DSCL9516D020Abro® Basic Multistratum® D2 95H16DSCL9516D022025-04-04
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