AccessGUDID - DEVICE: Lares Research (D95013133236U0)

GUDID

Device Identifier (DI) Information

Brand Name: Lares Research
Version or Model: L5 557 ProStyle SF
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 13133-236U
Company Name: LARES RESEARCH

Primary DI Number: D95013133236U0
Issuing Agency: HIBCC
Commercial Distribution End Date: June 03, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 009127838 *Terms of Use

Device Description: Legacy 5 557 ProStyle SF Swivel Ceramic Bearing

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44909	Pneumatic dental scaling/debridement system handpiece	A holder for a detachable tip that functions as part of a pneumatic dental scaling/debridement system, designed to use compressed air to generate a vibrating action at the tip to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. Water is also fed through the handpiece and attached tip to assist in the process. It is typically designed with a standard 2-, 3-, or 4-hole connector utilizing the same connection to existing air-driven handpiece tubing and the water spray for lavage. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	Handpiece, Air-Powered, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141221	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ca07965d-75fa-436d-ad80-b7ea615f2e69
Public Version Date: June 11, 2024
Public Version Number: 2
DI Record Publish Date: June 07, 2023