FDA.report

CHAIRSIDE

Primary DI
10840481122139
Brand
CHAIRSIDE
Company
Zest Anchors, LLC
Model
09574
Device description
CHAIRSIDE Block Out Material
Published
2023-09-07
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
EIDSyringe, Restorative And Impression Material

Product Code Classifications

CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840481122132PrimaryGS10
10840481122139Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840481122132008404811221328404811221320840481122132
1084048112213910840481122139

GMDN Terms

TermDefinition
Gingiva bleaching protectorA non-sterile paste or gel-like substance designed to protect a patient's gums from the hydrogen peroxide (H2O2) found in teeth whitening agents used during chairside light-curing bleaching of the teeth. It is typically supplied in a disposable syringe and is applied with an applicator along the gingiva leaving the teeth exposed for treatment. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Total Volume1.2Milliliter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)649-0084quality@zestdent.com

Regulatory Flags

DUNS number
078387192
Device count
4
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00840481135903LOCATOR Angled Abutment020992026-02-18
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00841336104891Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
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00841336104914Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
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20840326424302DefendYoung Innovations, Inc.EID2025-09-05
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E217150231Application TipsKettenbach GmbH & Co. KGEID2025-04-03