FDA.reportPublic FDA data

Paul Banditt

Primary DI
D955ELE34S0CUR1
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
ELE34S0CUR
Device description
PAUL BANDITT 34S0 CURVED ROOT ELEVATOR, STANDARD HANDLE
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMGForceps, Tooth Extractor, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMGForceps, Tooth Extractor, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D955ELE34S0CUR1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental elevator, tooth/rootA hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
177465051
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D95516CASS1Paul Banditt16CASS2026-09-25
D9555CASS1Paul Banditt5CASS2026-09-25
D9558CASS1Paul Banditt8CASS2026-09-25
D955BBCG35450Paul BandittBBCG35452026-09-25
D955BBGA351Paul BandittBBGA352026-09-25
D955BBGA451Paul BandittBBGA452026-09-25
D955BBGA551Paul BandittBBGA552026-09-25
D955BBGA701Paul BandittBBGA702026-09-25
D955BDT11Paul BandittBDT12026-09-25
D955BDT21Paul BandittBDT22026-09-25
D955BDT31Paul BandittBDT32026-09-25
D955BDT61Paul BandittBDT62026-09-25
D955BDT71Paul BandittBDT72026-09-25
D955BDT81Paul BandittBDT82026-09-25
D955BDT91Paul BandittBDT92026-09-25
D955BLAHST1Paul BandittBLAHST2026-09-25
D955BMDG010Paul BandittBMDG-012026-09-25
D955BMDG021Paul BandittBMDG-022026-09-25
D955BMDG031Paul BandittBMDG-032026-09-25
D955BONDNG1Paul BandittBONDNG2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955ROWDISL1Paul BandittTerlain Enterprises, Inc.EMG2026-09-25
D955ROWDISR1Paul BandittTerlain Enterprises, Inc.EMG2026-09-25
00190776411084MillenniumAvalign Technologies, Inc.EMG2026-08-07
G879100001A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMG2026-07-31
00190776403676MillenniumAvalign Technologies, Inc.EMG2026-07-21
00190776403232MillenniumAvalign Technologies, Inc.EMG2026-07-19
00850083275556Intrace USAPILOTIS TECH LLCEMG2026-07-03
G149TBSB7010TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7020TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7030TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7040TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7050TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7060TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7070TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7080TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7090TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7100TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7110TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7120TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7130TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7140TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7150TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7160TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7170TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7180TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7190TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7200TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7210TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7220TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7230TBS BASICSACME ENTERPRISE.EMG2026-05-21