Duns Number:439240722
Device Description: 040CRM - DISPOSABLE device in plastic material to be embodied in a removable prosthesis. C 040CRM - DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with soft retention 151BAM - SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis.150BPM - SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis.042AMM - SINGLE USE castable device Housing for retentive caps101PPM - SINGLE USE plastic device. Centering ring for castable housings
Catalog Number
099BSM
Brand Name
DENTAL ATTACHMENTS
Version/Model Number
OT CAP & MONO OT BOX MICRO size
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
4631b6c1-6cbb-48f6-a495-4b72477df711
Public Version Date
August 05, 2021
Public Version Number
1
DI Record Publish Date
July 28, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1987 |