FDA.report

Abro Basic Mono Bleach 95H13

Primary DI
D800DSAL9513BLE0
Brand
Abro Basic Mono Bleach 95H13
Company
ZIRKONZAHN SRL
Model
DSAL9513BLE
Device description
Content: 1 piece Height: 13 mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. Specifically designed for the production of denture teeth, long-term temporaries as well as secondary and tertiary structures.
Published
2023-09-29
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
false

Related Records

Contact Domains

Product Codes

CodeName
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D800DSAL9513BLE0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental bridge, polymerA custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

Sterilization Methods

Method

Contacts

PhoneEmail
+390474066660info@zirkonzahn.com

Regulatory Flags

DUNS number
564251911
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D800SY16600ZIRKONZAHN.Implant-Planner incl. Bone & Tooth SegmentationSY16602025-09-05
D800SY16700ZIRKONZAHN.Implant-Planner Practice incl. Bone & Tooth SegmentationSY16702025-09-05
D800DSCL9516A010Abro® Basic Multistratum® A1 95H16DSCL9516A012025-04-04
D800DSCL9516A020Abro® Basic Multistratum® A2 95H16DSCL9516A022025-04-04
D800DSCL9516A030Abro® Basic Multistratum® A3 95H16DSCL9516A032025-04-04
D800DSCL9516A040Abro® Basic Multistratum® A4 95H16DSCL9516A042025-04-04
D800DSCL9516A350Abro® Basic Multistratum® A3,5 95H16DSCL9516A352025-04-04
D800DSCL9516B010Abro® Basic Multistratum® B1 95H16DSCL9516B012025-04-04
D800DSCL9516B020Abro® Basic Multistratum® B2 95H16DSCL9516B022025-04-04
D800DSCL9516B030Abro® Basic Multistratum® B3 95H16DSCL9516B032025-04-04
D800DSCL9516B040Abro® Basic Multistratum® B4 95H16DSCL9516B042025-04-04
D800DSCL9516BLE0Abro® Basic Multistratum® Bleach 95H16DSCL9516BLE2025-04-04
D800DSCL9516C010Abro® Basic Multistratum® C1 95H16DSCL9516C012025-04-04
D800DSCL9516C020Abro® Basic Multistratum® C2 95H16DSCL9516C022025-04-04
D800DSCL9516C030Abro® Basic Multistratum® C3 95H16DSCL9516C032025-04-04
D800DSCL9516C040Abro® Basic Multistratum® C4 95H16DSCL9516C042025-04-04
D800DSCL9516D020Abro® Basic Multistratum® D2 95H16DSCL9516D022025-04-04
D800DSCL9516D030Abro® Basic Multistratum® D3 95H16DSCL9516D032025-04-04
D800DSCL9516D040Abro® Basic Multistratum® D4 95H16DSCL9516D042025-04-04
D800DSCL98S16A010Abro® Basic Multistratum® A1 98H16 with stepDSCL98S16A012025-04-04

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