FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677025388
Brand
PDT, Inc.
Company
PDT, INC.
Model
R098MB
Catalog number
R098MB
Device description
Montana Black 23
Published
2026-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677025388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677025388008136770253888136770253880813677025388

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""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
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
00813677022882PDT, Inc.T234 Aspirating Anesthetic Syringe SmallT2342024-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G149TBSB5030TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5040TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5110TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5150TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5190TBS BASICSACME ENTERPRISE.EMN2026-05-20
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EZPF2423806HF0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2026-04-13
EZPF2423823A0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2026-04-13
08800075614841OSUNG MNDOSUNG MND Co., Ltd.EMN2025-11-03
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07898506810888QuinelatoSchobell Industrial LtdaEMN2023-01-09
EZPFKS242880HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2022-12-16
08800000981444Metal ScalerOsstem Implant Co., Ltd.EMN2022-12-08
08800000981451Metal ScalerOsstem Implant Co., Ltd.EMN2022-12-08
08800000981468Metal ScalerOsstem Implant Co., Ltd.EMN2022-12-08
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