FDA.report

Chairside

Primary DI
00840481117954
Brand
Chairside
Company
Zest Anchors, LLC
Model
09573-01
Catalog number
09573-01
Device description
Cartridge [Chairside Soft Reline]
Published
2019-03-01
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
00840481117954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840481117954008404811179548404811179540840481117954

GMDN Terms

TermDefinition
Denture reliner, soft, professionalA denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Weight52Gram

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(760)743-7744cindy.harvell@zestanchors.com

Regulatory Flags

DUNS number
078387192
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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