FDA.reportPublic FDA data

PERIODONTAL EXPLORER TUFTS

Primary DI
00192896050150
Brand
PERIODONTAL EXPLORER TUFTS
Company
SONTEC INSTRUMENTS, INC.
Model
1102-EXTU17-23
Catalog number
1102-EXTU17-23
Device description
PERIODONTAL EXPLORER TUFTS #17-23 DOUBLE ENDED TIPS STANDARD HANDLE
Published
2018-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896050150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896050150001928960501501928960501500192896050150

GMDN Terms#

Term, Definition table
TermDefinition
Dental explorerA hand-held manual dental instrument designed for tactile examination (i.e., exploration) in the oral cavity, on the tooth surface and/or gums, mainly to find indentations (e.g., pits, fissures) for the determination of early tooth decay on the crown of teeth; it is also used in periodontology (e.g., to locate subgingival deposits before scaling). It is a long, slender instrument (a manual probe) with a stem that terminates in a thin working part at the distal end which may be needle-like, hooked, or blunt according to the intended use. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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00192896015272ENUCLEATION SCISSORS13-980513-98052018-09-13
00192896015289ENUCLEATION SCISSORS13-981013-98102018-09-13
00192896015296ENUCLEATION SCISSORS13-982013-98202018-09-13
00192896017214CASTROVIEJO LIP GRAFT CLAMP FORCEPS14-972514-97252018-09-17
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00192896081642LUXATOR ELEVATOR1100-586C21100-586C22018-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
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08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
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08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
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