FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677024886
Brand
PDT, Inc.
Company
PDT, INC.
Model
R922 PDT Oral Surgery Kit
Catalog number
R922
Device description
"Kit Includes:T015E-U E-Series FlipTop™ Casstte - UtilityR245 Cone Socket Mirror HandleR256 Anterior PeriotomeR258 Posterior PeriotomeR437 Lucas 86T018FM Silicone Finger MatT050 #5 Mirror (15/16"")T100 Caewood-Minnesota RetractorT103 Seldin 34 Root ElevatorT235 Aspirating Anesthetic Syringe MediumT714 Crile Wood Tungsten Carbide Needle Holder (15cm)T730 Friedman Bone RongeurT740 Prichard Periosteal ElevatorT790 150 Extra Grip Extracting ForcepsT792 151 Extra Grip Extracting ForcepsT800 Iris Curved Scissors (11.5cm)T820 LaGrange Scissors (11.5cm)"
Published
2024-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EAXMirror, Mouth
EGNScissors, Surgical Tissue, Dental
EICSyringe, Periodontic, Endodontic, Irrigating
EIFAccessories, Retractor, Dental
EMGForceps, Tooth Extractor, Surgical
EMHForceps, Rongeur, Surgical
EMJElevator, Surgical, Dental
EMKCurette, Surgical, Dental
EMOKnife, Periodontic
FSMTray, Surgical, Instrument
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1
EGNScissors, Surgical Tissue, DentalDental1
EICSyringe, Periodontic, Endodontic, IrrigatingDental1
EIFAccessories, Retractor, DentalDental1
EMGForceps, Tooth Extractor, SurgicalDental1
EMHForceps, Rongeur, SurgicalDental1
EMJElevator, Surgical, DentalDental1
EMKCurette, Surgical, DentalDental1
EMOKnife, PeriodonticDental1
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677024886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024886008136770248868136770248860813677024886

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose curetteA hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use 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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00190776436803MillenniumAvalign Technologies, Inc.HXK2026-10-21
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00889024699892IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699908IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699915Comprehensive HumeralZimmer, Inc.FSM2026-10-21
00889024699922Identity HumeralZimmer, Inc.FSM2026-10-21
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