IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
FDA 510(k) clearance K123278 · decided 2012-12-07
Clearance details
- K-number
- K123278
- Device name
- IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
- Applicant
- Heraeus Kulzer, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-10-22
- Decision date
- 2012-12-07
- Days to decision
- 46 days
- Clearance type
- Special
- Product code
- KLE
- Device class
- 2
- Regulation number
- 872.3200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- South Bend, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Heraeus Kulzer
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Any-Etch (K260485) | Mediclus Co., Ltd. | 2026-05-14 |
| Porcelain Etch Gel (K260430) | Belport Company, Inc., Gingi-Pak | 2026-04-10 |
| Adhese 2 (K252450) | Ivoclar Vivadent, Inc. | 2026-03-05 |
| Bond-PR™ Universal Adhesive (K260682) | Premier Dental Products Company | 2026-03-03 |
| VITA VMLC Primer (K251587) | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026-02-23 |
| els unibond (K252151) | Saremco Dental AG | 2025-12-05 |
| MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (K252469) | Dmp Dental Industry S.A. | 2025-11-06 |
| G-Bond Universal (K251124) | GC America, Inc. | 2025-10-02 |
| HF-Etchant Hydrofluoric Acid Etching Gel (K242530) | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 |
| TopCEM Ceramic Primer Ceramic Coupling Agent (K242749) | Rizhao Huge Biomaterials Company, Ltd. | 2024-11-08 |
| FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) (K242675) | Spident Co., Ltd. | 2024-11-01 |
| Ceramic Etchant (HF-5 and HF-9) (K240153) | Liaoning Upcera Co., Ltd. | 2024-10-02 |
Recalls involving this device
No recalls on record reference this clearance.