FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Encore!
DI: 00190730004635
·
Model: MC-021
·
ORTHO TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Encore!
- Primary DI
- 00190730004635
- Version / Model
- MC-021
- Company Name
- ORTHO TECHNOLOGY, INC.
- Labeler DUNS
- 781772017
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2025-01-07
- Public Version Status
- Update
- Public Device Record Key
- 32767cf1-aa6e-4587-9ba9-55efc427c36c
- Distribution End Date
- 2024-09-18
Device Description
Encore! Ceramic 018 UR3 Hk Roth Rx 0° Tor. +11° Ang.(10PK)
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| NJM | Bracket, ceramic, orthodontic | Dental | 872.5470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58937 | Orthodontic bracket, ceramic | A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190730004635 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922499 | 000 |