DEVICE: NV® (D813ZLR1012A1)

Device Identifier (DI) Information

NV®
ZLR1012A
In Commercial Distribution
ZLR1012A
DEN-MAT HOLDINGS, LLC
D813ZLR1012A1
HIBCC

25
809857704 *Terms of Use
NV DISP REG TIPS 5MM 25/PK
CLOSE

Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental diode laser system A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite a diode to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation to cut, excise, vaporize, and coagulate tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, diminish inflammation, oral therapy and tooth whitening. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GEX Powered Laser Surgical Instrument
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K081214 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 5 Millimeter
CLOSE

Device Record Status

1b1392fe-3e3c-4d72-8650-faffd35e8e39
July 06, 2018
3
September 24, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: D813ZLR1012A0 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-800-433-6628
info@denmat.com
CLOSE