Identity
- Trade Name
- Surgical Instrument FDA UDI
- Generic Name
- Orthodontic appliance/positioning tray kit FDA UDI
- Model / Reference
- 112-070 KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800089434176 FDA UDI
- 510(k) Number
- K161335 FDA UDI
- FDA Product Code
- OAT FDA UDI
- GMDN Term
- Orthodontic appliance/positioning tray kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthodontic appliance/positioning tray kit
Surgical Instrument by Jeil Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic appliance/positioning tray kit.
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- Inbrace Teeth Straightening System — SWIFT HEALTH SYSTEMS INC. · Class II
- Indirect Bond — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. · Class I
- Indirect Bonding Tray — Six Month Smiles · Class I
- Indirect Bond-EZ_HardSoft — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. · Class I
- Inbrace Teeth Straightening System — SWIFT HEALTH SYSTEMS INC. · Class II
Cleared under the same submission
K161335 also covers:
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jeil Medical Corporation
Sources (1)
- FDA UDI 942c00e5-d44d-4985-a2b1-945cf1edfe5f 33 fields · synced May 30, 2026