PDT, Inc.

Basic Information

• Brand Name: PDT, Inc.
• Primary DI: 00813677029324
• Version / Model: R932 Ultimate Implant Kit
• Catalog Number: R932
• Company Name: PDT, INC.
• Labeler DUNS: 125850144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-22
• Public Version: 1
• Public Version Date: 2024-05-30
• Public Version Status: New
• Public Device Record Key: 913e534a-06e3-48b4-ae19-5a39dbced7c0

Device Description

Kit Containing: R138T - Montana Jack Titanium R696 - Amazing Gracey 13-14 Titanium Extended Reach Micro Mini R630 - Pineyro Arch Ti1 R631 - Pineyro Arch Ti2 R632 - Pineyro Arch Ti3 R633 - Pineyro Arch Ti4 R661 - Wingrove B 5-6 Titanium Implant R680 - Wingrove L 3-4 Titanium Implant R693 - Wingrove N128 Blunt-Langer 5 Mini Titanium Implant T216 - EasyView UNC12 Probe T061 - Diamond Head Ceramic Stone E-Z Jett Cassette 10-Place

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Dry Heat Sterilization, Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMN	Scaler, Periodontic	Dental	872.4565	1
EMS	Curette, Periodontic	Dental	872.4565	1
EIX	Probe, Periodontic	Dental	872.4565	1
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12143	Instrument tray, reusable	A 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.	No	Active
35320	Manual dental scaler, reusable	A 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.	No	Active
35812	Dental surgical probe, reusable	A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.	No	Active
41660	Periodontal curette	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813677029324	GS1