510(k) K251124
- Device
- G-Bond Universal
- Applicant
- GC America, Inc.
- 510(k) number
- K251124
- Product code
- KLE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-02
- Date received
- 2025-04-11
- Regulation
- 872.3200
- Classification name
- Agent, Tooth Bonding, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Futoshi Fusejima
- Address
- 3737 W. 127th St. Alsip IL US 60803 60803
FDA Registration Numbers
- 3002789526
- 3005176727
- 1410097
- 3013584861
- 9612352
- 3006316962
- 2916735
- 1281412
- 3039433962
- 3017674095
- 1420052
- 1420089
- 3031841433
- 9681356
- 2086043
- 3013557697
- 1125730
- 2433629
- 3032378317
- 3006694515
- 3012187973
- 8030067
- 1424442
- 3005665377
- 3012354669
- 3004475754
- 8044038
- 9613953
- 3003449480
- 3002807050
- 3014270094
- 3008912871
- 3032312561
- 1215305
- 3010131268
- 3015272949
- 8010908
- 1815540
- 2511556
- 2027375
- 1000118628
- 3012627824
- 1413399
- 2424472
- 1718476
- 3003621174
- 2024980
- 3038718579
- 9615399
- 3026400121
- 3027616
- 2411797
- 9681210
- 3010419931
- 3007113445
- 1000272892
- 3010864832
- 3032027578
- 2244812
- 3010002722
- 3008966075
- 2515379
- 3007584711
- 3043226252
- 8020994
- 1032227
- 3005628474
- 3004425647
- 3005974404
- 3009603151
- 3011148229
- 9612300
- 9614573
- 1413475
- 3015189878
- 2126683
- 2429849
- 8010638
- 8044164
Source Documents
Other 510(k) Records For Product Code KLE
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260485 | Any-Etch | Mediclus Co., Ltd. | 2026-05-14 |
| K260430 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | 2026-04-10 |
| K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | 2026-03-05 |
| K260682 | Bond-PR™ Universal Adhesive | Premier Dental Products Company | 2026-03-03 |
| K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026-02-23 |
| K252151 | els unibond | Saremco Dental AG | 2025-12-05 |
| K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. | 2025-11-06 |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. | 2024-11-08 |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | Spident Co., Ltd. | 2024-11-01 |
| K240153 | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd. | 2024-10-02 |
| K241445 | K-Bond Universal | Spident Co., Ltd. | 2024-07-22 |
| K241056 | Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd. | 2024-07-16 |
| K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024-03-20 |
| K231039 | CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. | 2023-12-13 |