DEVICE: Dental LT Clear Resin V2 (00860002099330)

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Device Record History
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Device Identifier (DI) Information
Dental LT Clear Resin V2
FLDLCL02
In Commercial Distribution
FLDLCL02
FORMLABS OHIO INC.
00860002099330
GS1

1
106744280 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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?
16730 Dental appliance fabrication material, resin
A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KMY Positioner, Tooth, Preformed
DYT Maintainer, Space Preformed, Orthodontic
MQC Mouthguard, Prescription
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 50 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Keep out of sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
e04f12a0-ccb7-4473-9281-dd5a472ecebe
March 13, 2024
5
July 07, 2020
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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
10860002099337 8 00860002099330 In Commercial Distribution Case
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Secondary DI

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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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