FDA.reportPublic FDA data

Paul Banditt

Primary DI
D955ELEX14L1
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
ELEX14L
Device description
PAUL BANDITT 14L ELEVATOR, T BAR STYLE
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
D955ELEX14L1PrimaryHIBCC0

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
D955CRO1081Paul BandittCRO108 2023-12-11
D955CRO27081Paul BandittCRO2708 2023-12-11
D955CRO27091Paul BandittCRO2709 2023-12-11
D955CRO2709I1Paul BandittCRO2709I 2023-12-11
D955CRO3T1Paul BandittCRO3T 2023-12-11
D955CRO49281Paul BandittCRO4928 2023-12-11
D955CRO49311Paul BandittCRO4931 2023-12-11
D955CROPORI1Paul BandittCROPORI 2023-12-11
D955CROPORL1Paul BandittCROPORL 2023-12-11
D955CROPORU1Paul BandittCROPORU 2023-12-11
D955CROTIPA1Paul BandittCROTIPA 2023-12-11
D955CROTIPB1Paul BandittCROTIPB 2023-12-11
D955CROTIPC1Paul BandittCROTIPC 2023-12-11
00860011605706Surgi-StopSDWD-01 2024-01-29
10860011605703Surgi-StopSDWD-01 2024-01-29
D9553300KEY1Paul Banditt3300-KEY 2023-12-11
D95543411Paul Banditt434-1 2023-12-11
D955BC169511Paul BandittBC1695-12023-12-11
D955BC169521Paul BandittBC1695-2 2023-12-11
D955BCU0R0L1Paul BandittBCU0R0L 2023-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G149TBSB7240TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7250TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7260TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7270TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7280TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7290TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7310TBS BASICSACME ENTERPRISE.EMG2026-05-21