AccessGUDID - DEVICE: DENTAL ATTACHMENTS (D821040CRN0)

GUDID

Device Identifier (DI) Information

Brand Name: DENTAL ATTACHMENTS
Version or Model: CLEAR CAPS STANDARD size x6
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 040CRN
Company Name: RHEIN 83 SRL

Primary DI Number: D821040CRN0
Issuing Agency: HIBCC
Commercial Distribution End Date: January 20, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 439240722 *Terms of Use

Device Description: DISPOSABLE device in plastic material to be embodied in a removable prosthesis.To provide retention with the anchorage provided by the corresponding metal attachment fixed in the mouth.

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:	Yes
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?
64322	Dental precision attachment fitting/adjustment tool	A manual dental laboratory instrument intended to be used in a dental laboratory during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments. It is in the form of a handle with a distal end designed to perform a dedicated function (e.g., facilitate the parallel placement of a male attachment, remove/exchange/adjust an attachment, insert a retention insert, tighten a screwable element of an attachment); some types may be heated to enable melting, or attached to a motorized handpiece (e.g., drill). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGG	Attachment, Precision, All

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 6c3df576-f5ac-47ad-9ae4-e9d6c0c5e2b3
Public Version Date: January 21, 2021
Public Version Number: 2
DI Record Publish Date: December 22, 2020