FDA.report

PILLING

Primary DI
54026704803441
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN907128
Catalog number
P25985
Device description
LUCAS CURETTE #2R-2L 7"
Published
2022-12-08
Public version status
Update
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
EKTCURETTE, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKTCurette, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
54026704803441Direct MarkingGS10
14026704803443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5402670480344154026704803441
1402670480344314026704803443

GMDN Terms

TermDefinition
Periodontal file/rasp, manualA hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This device is typically used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), and remove overhanging margins of dental restorations. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
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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