Identity
- Trade Name
- IBOND UNIVERSAL BOTTLE INTRO KIT FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- Agent, tooth bonding resin FDA UDI
- Model / Reference
- 66061413 FDA UDI
- Description
- Agent, tooth bonding resin FDA UDI
Identifiers
- Catalog Number
- 66061413 FDA UDI
- Primary DI / UDI-DI
- J014660614130 FDA UDI
- 510(k) Number
- K150933 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dentine bonding agent/set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Ibond Universal Bottle Intro Kit by Kulzer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K150933 also covers:
- IBOND CERAMIC PRIMER 1x4ml — Kulzer, Inc.
- IBOND UNIVERSAL BOTTLE REFILL 1x4ml — Kulzer, Inc.
- IBOND UNIVERSAL BOTTLE SAMPLE 1 x 2ML — Kulzer, Inc.
- IBOND UNIVERSAL BOTTLE VALUE PACK 3x4ml — Kulzer, Inc.
- IBOND UNIVERSAL SD SAMPLE 2 pcs — Kulzer, Inc.
- IBOND UNIVERSAL SINGLE DOSE VALUE PACK — Kulzer, Inc.
- iBond — Kulzer, Inc.
- iBond Universal — Kulzer, Inc.
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 |
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Manufacturer
- Manufacturer
- Kulzer, Inc.
Sources (1)
- FDA UDI ca54e0bd-cb6f-499f-abe1-d0e8f59eede6 37 fields · synced May 29, 2026