510(k) K072480
- Device
- GENERATION 8 SE ADHESIVE
- Applicant
- PENTRON CLINICAL TECHNOLOGIES
- 510(k) number
- K072480
- Product code
- KLE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-11-21
- Date received
- 2007-09-04
- 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
- No
Applicant Contact#
- Contact
- GREG MARCEAU
- Address
- 68-70 N. Plains Industrial Rd. Wallingford CT US 06492 06492
FDA Registration Numbers#
- 9680845
- 3008582054
- 8010638
- 1718912
- 3012477813
- 1125730
- 3002807420
- 2024980
- 3000219976
- 3008005217
- 3002807050
- 1032227
- 3011689956
- 8010908
- 3004425647
- 1718476
- 1013257
- 3003449480
- 1420052
- 3004140838
- 3004966444
- 2411797
- 2433629
- 9615399
- 3006316962
- 2183301
- 1281412
- 2515379
- 8030067
- 9616128
- 3005665377
- 1000118628
- 3012187973
- 3008966075
- 2014676
- 3013508670
- 3035693034
- 8020994
- 2023950
- 3008882689
- 3032312561
- 2027375
- 1000625496
- 9610902
- 3008912871
- 3013557697
- 2126683
- 3014270094
- 8044164
- 3007584711
- 3010131268
- 2024312
- 3005974404
- 2429849
- 2018957
- 8010711
- 3007113445
- 2022039
- 3044819802
- 3011649314
- 3032163716
- 1450653
- 3017674095
- 3039433962
- 1413399
- 2081055
- 3015272949
- 3026400121
- 3015189878
- 3014615644
- 9611385
- 3013411964
- 3007210751
- 3032027578
- 3011824442
- 3006223010
- 9681254
- 2523320
- 3042272797
- 3009496224
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 |
| K251124 | G-Bond Universal | GC America, Inc. | 2025-10-02 |
| 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 |
Legacy Summary#
summary
FDA Review#
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