FDA UDI
In Commercial Distribution
🇺🇸 United States
Erkoflex-bleach
DI: ERKO5815101
·
Model: 581510
·
Erkodent Erich Kopp GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Erkoflex-bleach
- Primary DI
- ERKO5815101
- Version / Model
- 581510
- Company Name
- Erkodent Erich Kopp GmbH
- Labeler DUNS
- 317654200
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-21
- Public Version
- 1
- Public Version Date
- 2021-09-29
- Public Version Status
- New
- Public Device Record Key
- 3281b8c4-0362-4f82-8e74-6d4ab200d7b2
Device Description
Erkoflex-bleach, 1.00 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQC | Mouthguard, Prescription | Unknown | U | |
| KMY | Positioner, Tooth, Preformed | Dental | 872.5525 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58288 | Dental appliance fabrication material, thermoplastic | A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ERKO5815101 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200125 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 95 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 35 Degrees Celsius