OCTAGON Infinity TL RP Abutment angled 15° A H= 5.7 mm cementable
| Catalog Number: | 5082648 |
|---|---|
| Company Name: | Hager & Meisinger Gesellschaft mit beschränkter Haftung |
| Device Combination Product: | N/A |
| Device Commercial Dsitribution End Date: | 2016-12-06 |
| Device Commercial Dsitribution Status: | Not in Commercial Distribution |
| Device Count: | 1 |
| Device Description: | Abutment angled 15° A H= 5.7 mm cementable for OCTAGON Infinity Dental Implant RP |
| Device hctp: | N/A |
| Device kit: | N/A |
| Device Publish Date: | 2016-09-08 |
| Device Record Status: | Published |
| Direct Market Exempt: | N/A |
| Has Donation ID number? | N/A |
| DUNS Number: | 318034329 |
| Has Expiration Date? | N/A |
| Is Labelled as NRL: | N/A |
| Is Labelled As No NRL: | N/A |
| Has Lot Batch Number: | true |
| Has Manufacutring Date: | N/A |
| MRI Safety Status: | Labeling does not contain MRI Safety Information |
| Is OTC? | N/A |
| Is Devic Premarket Exempt: | N/A |
| Public Device Record Key: | dfd455f2-4fb6-412e-a3d7-c96b5215abf5 |
| Public Version Date: | 2019-11-08 |
| Public Version Number: | 6 |
| Public Version Status: | Update |
| Is Rx? | true |
| Has Serial Number? | N/A |
| Is Single Use: | true |
| Version Model Number: | 5082648 |
| Adress: | Phone:+1(508)588-3100 Extension: Email: kathystrange@acesurgical.com |
Storage Condition
Storage Handling Type
Storage Handling High
Storage Handling Low
Storage Handling Special Condition
N/A
N/A
N/A
N/A
GMDN Terms
GMDN Name
GMDN Term Definition
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.
Identifiers
Device ID
Device ID Type
Issuing Agency
Contains DI No
Pkg Qty
Pkg Discontinue dt
Pkg Status
Pkg Type
XXXX50826489
Primary
HIBCC
Sterilization
Is Device Sterile
Is Steriliztion Prior Use
Sterilization Method
false
true
{"sterilization_method"=>"Moist Heat or Steam Sterilization"}
Product Codes
Product Code
Product Code Name
NHA
Abutment, Implant, Dental, Endosseous
Pre Market Submisison
Submission Number
Supplement Number
N/A
N/A