AccessGUDID - DEVICE: ERA® RV Males (2 blk, 2 wht, 1 org). (00841549101007)

GUDID

Device Identifier (DI) Information

Brand Name: ERA® RV Males (2 blk, 2 wht, 1 org).
Version or Model: 811113
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STERNGOLD DENTAL LLC

Primary DI Number: 00841549101007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124763728 *Terms of Use

Device Description: Package contains 2-each Black & White ERA males, and 1 orange male. Attachments are two-part connectors. One part is intraorally fixed as part of a fixed (i.e. not patient removable) dental restoration, and a replaceable, high density nylon male anchored into a patient removable dental prosthesis (denture base). When the removable prosthesis is seated in the mouth the attachment parts come together and secure it in place. In other applications the attachment connects two sections of a segmented fixed partial denture.

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?
38603	Resilient dental precision attachment	A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHA	Abutment, Implant, Dental, Endosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K913348	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: 47671248-228e-4e6b-a5de-7eab02417c42
Public Version Date: January 09, 2020
Public Version Number: 4
DI Record Publish Date: February 23, 2017