FDA UDI
In Commercial Distribution
🇺🇸 United States
Planmeca Compact
DI: 06430035420612
·
Model: i3
·
Planmeca Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Planmeca Compact
- Primary DI
- 06430035420612
- Version / Model
- i3
- Catalog Number
- 30021331, 30021332
- Company Name
- Planmeca Oy
- Labeler DUNS
- 368788568
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-29
- Public Version
- 1
- Public Version Date
- 2019-11-06
- Public Version Status
- New
- Public Device Record Key
- be709fe4-babe-464d-bcbe-66ddea156ded
Device Description
Planmeca Compact i3 is a dental operative unit with a dental patient chair. The unit is equipped with a digital control system and a user interface with a touch panel. The instrument console includes five instrument locations, with easy instrument change. The chair and the unit can be swiveled and it is suitable for both right and left-handed use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIA | Unit, Operative Dental | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34991 | Dental delivery system | A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430035420612 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K961420 | 000 |