FDA.report

SCOTT'S SELECT CARVER DE # IPC-1

Primary DI
D77812815940
Brand
SCOTT'S SELECT CARVER DE # IPC-1
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
128-1594
Catalog number
128-1594
Device description
CARVER (1/pack) End: Double End, Size: IPC-1, Handle: Standard; For more information: https://www.scottsdental.com/catalog/product/view/id/29892/s/carvers-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
EKHCARVER, DENTAL AMALGAM, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKHCarver, Dental Amalgam, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77812815940PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental restoration carver, multiple-materialA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in multiple dental restoration materials such as amalgam, cement, and acrylic or composite resin/plastic (i.e., not dedicated to a particular material) by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It is typically 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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D77819950610Scott's Select ColorFil Flow Single-Shade Prismatic199-5061199-50612024-08-27
D77819950630Scott's Select ColorFil Flow Blocker199-5063199-50632024-08-27
D77819950500Scott's Select ColorFil Single-Shade Prismatic199-5050199-50502024-08-26
D77819950530Scott's Select ColorFil Blocker199-5053199-50532024-08-26
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D77835055000Scott's Select Nitrile Gloves350-5500350-55002024-08-22
D77835055050Scott's Select Nitrile Gloves350-5505350-55052024-08-22
D77835055110Scott's Select Nitrile Gloves350-5511350-55112024-08-22
D77835086300Scott's Select Latex Gloves350-8630350-86302024-08-22
D77835086320Scott's Select Latex Gloves350-3632350-36322024-08-22
D77835086340Scott's Select Latex Gloves350-8634350-86342024-08-22

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