FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677025258
Brand
PDT, Inc.
Company
PDT, INC.
Model
AU026 Gracey 11/12
Catalog number
AU026
Device description
AU026 Paragon Care Gracey 11/12
Published
2025-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMSCurette, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677025258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677025258008136770252588136770252580813677025258

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Regulatory Flags#

DUNS number
125850144
Device count
1
Premarket exempt
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
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
00813677022882PDT, Inc.T234 Aspirating Anesthetic Syringe SmallT2342024-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879102188H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102198H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102207H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102208H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102209H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102210H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102214H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102215H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102216H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC15160DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC17180DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC9100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM9100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14