FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677024978
Brand
PDT, Inc.
Company
PDT, INC.
Model
R937 PDT Total Restorative Kit
Catalog number
R937
Device description
"Kit Includes:(T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider(R138) Montana Jack™(R223) 23 Explorer-12 Probe(R245) Cone Socket Mirror Handle(R269) 3-6 Discoid-Cleoid Carver(R284) Hollenback 1/2-3 Carver(R286) G2 Thin Composite(R287) G3 Thin Composite(R333) 27-29 Burnisher(R336) Calcium Hydroxide Placer(R347) 0-1 Blacks Plugger(R362) 113 Off Angle Cord Packer(R375) Mixing Spatula-Applicator(R386) 38-39 Excavator(R534) IPC-T Gold Line™ (Composite Sculpting System)(T042) Meriam Tweezers(T046) Miller Articulating Paper Forceps(T050) #5 Mirror (15/16"")(T235) Aspirating Anesthetic Syringe Medium(T356) Amalgam Well(T800) Iris Curved Scissors (11.5cm)"
Published
2024-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand
EAXMirror, Mouth
EGNScissors, Surgical Tissue, Dental
EICSyringe, Periodontic, Endodontic, Irrigating
EIXProbe, Periodontic
EIYInstrument, Filling, Plastic, Dental
EJBHandle, Instrument, Dental
EJYPliers, Operative
EKBExplorer, Operative
EKCExcavator, Dental, Operative
EKGCondenser, Amalgam And Foil, Operative
EKHCarver, Dental Amalgam, Operative
EKICarrier, Amalgam, Operative
EKJBurnisher, Operative
EMNScaler, Periodontic
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1
EAXMirror, MouthDental1
EGNScissors, Surgical Tissue, DentalDental1
EICSyringe, Periodontic, Endodontic, IrrigatingDental1
EIXProbe, PeriodonticDental1
EIYInstrument, Filling, Plastic, DentalDental1
EJBHandle, Instrument, DentalDental1
EJYPliers, OperativeDental1
EKBExplorer, OperativeDental1
EKCExcavator, Dental, OperativeDental1
EKGCondenser, Amalgam And Foil, OperativeDental1
EKHCarver, Dental Amalgam, OperativeDental1
EKICarrier, Amalgam, OperativeDental1
EKJBurnisher, OperativeDental1
EMNScaler, PeriodonticDental1
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677024978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024978008136770249788136770249780813677024978

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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

Regulatory Flags#

DUNS number
125850144
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813677025395PDT, Inc.R117 Boge Precision DuoR1172026-05-12
00813677025388PDT, Inc.R098MB R098MB2026-04-27
00813677023230PDT, Inc.T732 Stieglitz 30° Splinter ForcepT7322024-07-02
00813677025364PDT, Inc.T055-3 Double-Sided PrecisionReflect HD Mirror ThrT055-32025-10-20
00813677025371PDT, Inc.T055-6 Double-Sided PrecisionReflect HD Mirror TweT055-62025-10-20
00813677025326PDT, Inc."T050-3 #5 PrecisionReflect HD Mirror (15/16"") ThT050-32025-10-16
00813677025333PDT, Inc."T050-12 #5 PrecisionReflect HD Mirror (15/16"") TT050-122025-10-16
00813677025340PDT, Inc."T051-3 #4 PrecisionReflect HD Mirror (7/8"") ThreT051-32025-10-16
00813677025357PDT, Inc."T051-12 #4 PrecisionReflect HD Mirror (7/8"") ThrT051-122025-10-16
00813677025319PDT, Inc.T805 Beebee Crown Curved Scissors (10.5cm)T8052025-09-03
00813677025258PDT, Inc.AU026 Gracey 11/12AU0262025-08-14
00813677025265PDT, Inc.AU028 Gracey 13-14AU0282025-08-14
00813677025272PDT, Inc.AU061 Barnhart 5-6AU0612025-08-14
00813677025289PDT, Inc.AU110 H6-7AU1102025-08-14
00813677025296PDT, Inc.AU135 204SAU1352025-08-14
00813677025302PDT, Inc.AU138 Ouback JackAU1382025-08-14
00813677022455PDT, Inc.T044 Titanium TweezersT0442024-07-05
00813677023612PDT, Inc.T845 Bone Carrier (3.5mm)T8452024-07-02
00813677023629PDT, Inc.T846 Bone Carrier (4.5mm)T8462024-07-02
00813677023636PDT, Inc.T847 Bone Carrier (6mm)T8472024-07-02

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