DEVICE: PDT, Inc. (00813677025227)
Device Identifier (DI) Information
PDT, Inc.
R909 - PDT Wallet 3 Pack - Doctor
In Commercial Distribution
R909
PDT, INC.
R909 - PDT Wallet 3 Pack - Doctor
In Commercial Distribution
R909
PDT, INC.
Kit Contains:
R227 Explorer 23/Probe UNC-12
R518 CSS-3 Gold Line™ Composite Sculpting System
R362 113 Off Angle Cord Packer
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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| No | |
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| No | |
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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? |
|---|---|---|---|---|
| 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 |
| 38530 | Dental spatula, reusable |
A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.
|
Active | false |
| 64164 | Gingival retraction cord packing tool |
A hand-held manual dental instrument designed specifically to pack a gingival retraction cord between the tooth and the gingiva during abutment preparation. It is a metallic single- or double-ended device with a spatula-like tip(s) which may have serrated edges. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DZN | Instruments, Dental Hand |
| EIY | Instrument, Filling, Plastic, Dental |
| EKB | Explorer, Operative |
| EIX | Probe, Periodontic |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
e9b8c869-90f4-4fdf-8028-3c0aab9fe07d
April 02, 2025
1
March 25, 2025
April 02, 2025
1
March 25, 2025
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined