FDA.reportPublic FDA data

Obtura Spartan

Primary DI
00816168020015
Brand
Obtura Spartan
Company
OBTURA SPARTAN ENDODONTICS
Model
943-710
Catalog number
943-710
Device description
Autoclavable Endo Handpiece
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816168020015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816168020015008161680200158161680200150816168020015

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpieceA hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078371330
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816168020022Obtura Spartan943-610943-6102016-10-03
00816168020039Obtura Spartan941-100941-1002016-10-18
00816168020046Obtura Spartan942-100942-1002016-10-18
00816168020053Obtura Spartan941-400941-4002016-10-03
00816168020060Obtura Spartan941-500941-5002016-10-03
00816168020077Obtura Spartan941-600941-6002016-10-03
00816168020084Obtura Spartan941-700941-7002016-10-03
00816168020091Obtura Spartan930-016930-0162016-10-03
00816168020107Obtura Spartan930-017930-0172016-10-03
00816168020114Obtura Spartan930-018930-0182016-10-03
00816168020121Obtura Spartan941-157941-1572016-10-03
00816168020138Obtura Spartan941-147941-1472016-10-03
00816168020145Obtura Spartan940-035940-0352016-10-03
00816168020152Obtura Spartan931-116931-1162016-10-03
00816168020169Obtura Spartan930-115930-1152016-10-03
00816168020176Obtura Spartan930-608930-6082016-10-03
00816168020183Obtura Spartan931-011931-0112016-10-03
00816168020190Obtura Spartan931-012931-0122016-10-03
00816168020206Obtura Spartan931-013931-0132016-10-03
00816168020213Obtura Spartan931-014931-0142016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613353318581AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
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07613353343408PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353028374PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170318PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170325PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353223182PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353225117PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
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J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
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