FDA.report

SCOTT'S COMPOSITE PLACEMENT TNT # 5 (6 HDL)

Primary DI
D77812815310
Brand
SCOTT'S COMPOSITE PLACEMENT TNT # 5 (6 HDL)
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
128-1531
Catalog number
128-1531
Device description
COMPOSITE PLACEMENT TNT (1/pack) End: Double End, Size: 5, Handle: Lightweight; For more information: https://www.scottsdental.com/catalog/product/view/id/29894/s/tnt-composite-instruments-scott-s-select/
Published
2021-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77812815310PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental restoration carver, resinA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental composite or acrylic resin restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)901-3368info@scottsdental.com

Regulatory Flags

DUNS number
137217043
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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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