AccessGUDID - DEVICE: RP Cover Screw Internal Hex (00841549106972)

GUDID

Device Identifier (DI) Information

Brand Name: RP Cover Screw Internal Hex
Version or Model: 901016
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: STERNGOLD DENTAL LLC

Primary DI Number: 00841549106972
Issuing Agency: GS1
Commercial Distribution End Date: October 06, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 124763728 *Terms of Use

Device Description: Protects hex head, mating surfaces and internal threads of implants. A cover screw closes off the inside threads of a dental implant during the period of bone healing and implant integration. Healed gingival tissue covers the cover screw and implant.

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?
44879	Dental implant suprastructure, permanent, preformed	A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K924219	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: a8dd4dc0-9517-4e52-9863-5b590ae2f13b
Public Version Date: October 09, 2023
Public Version Number: 7
DI Record Publish Date: November 04, 2015