DEVICE: PDT, Inc. (00813677029324)

Device Identifier (DI) Information

PDT, Inc.
R932 Ultimate Implant Kit
In Commercial Distribution
R932
PDT, INC.
00813677029324
GS1

1
125850144 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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.
Active false
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.
Active false
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EMN Scaler, Periodontic
EMS Curette, Periodontic
EIX Probe, Periodontic
FSM Tray, Surgical, Instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

913e534a-06e3-48b4-ae19-5a39dbced7c0
May 30, 2024
1
May 22, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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