FDA.report

SET ZZ BASE Z-TS-ICCT 4.5 (Impression coping closed tray non hex and S

Primary DI
D800BSAQ1172
Brand
SET ZZ BASE Z-TS-ICCT 4.5 (Impression coping closed tray non hex and S
Company
ZIRKONZAHN SRL
Model
BSAQ1172
Device description
Compatible with Zimmer Dental Tapered Screw-Vent implants Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Cap for Impression coping closed tray
Published
2021-09-27
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
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D800BSAQ1172PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, reusableA 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 includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+390474066660info@zirkonzahn.com

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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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
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